вторник, 31 мая 2011 г.

Children With Depressive, Anxiety Disorders Have More Sleep Problems

For some children, sleep problems may result purely from poor sleep habits and inadequate sleep hygiene. However, for a small percentage of children, sleep problems might represent a pre-cursor or early symptom of a more serious emotional disorders, including anxiety and depression, according to a research abstract presented on Monday at SLEEP 2008, the 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS).



The study, authored by Flavia Giannotti, MD, of Center of Pediatric Sleep Disorders at the University of Rome La Sapienza in Italy, was conducted on 122 children between seven and 11 years of age, who had a major depressive disorder. All patients underwent a systematic psychiatric, cognitive and sleep evaluation. All children were medication-free. Depressed children, as well as those presenting a comorbid anxious disorder, entered the study, and their results were compared to those of 200 healthy peers.



According to the results, 82 percent of the depressed children reported a problematic sleep, compared to five percent of healthy controls. In the depressed group, 42 percent of comorbid children showed a significantly higher frequency of sleep onset insomnia, compared to 29 percent of the non-comorbid group. They scored significantly higher on the "bedtime difficulties", "sleep anxiety", and "sleep duration" portions of the Children's Sleep Habits Questionnaire than the non-comorbid group. Comorbid and non-comorbid depressed children showed a significant tendency to a later bedtime (50 minutes) and a more markedly fragmented sleep than controls (35 minutes). Twenty percent of comorbid depressed children shared their parents' bed (20 percent), compared to 17 percent of non-comorbid and five percent of healthy controls.



"Sleep problems are very common in typically developing children. Even though they are more frequent in toddlers and preschoolers, they affect also school-aged children. What was most interesting about this study was the finding that certain types of comorbid conditions might be especially disruptive on sleep. Therefore, in childhood, considerable attention needs to be paid to the interrelation between sleep patterns and emotional disorders. To ensure the most effective care, parents of sleep-disturbed children are advised to first consult with the child's pediatrician, who may issue a referral to a sleep specialist for comprehensive testing and treatment," said Dr. Giannotti.



It is recommended that school-aged children get between 10-11 hours of nightly sleep.



The American Academy of Sleep Medicine (AASM) offers some tips to help your child sleep better:
Follow a consistent bedtime routine. Set aside 10 to 30 minutes to get your child ready to go to sleep each night.















Establish a relaxing setting at bedtime.


Interact with your child at bedtime. Don't let the TV, computer or video games take your place.


Keep your children from TV programs, movies, and video games that are not right for their age.


Do not let your child fall asleep while being held, rocked, fed a bottle, or while nursing.


At bedtime, do not allow your child to have foods or drinks that contain caffeine. This includes chocolate and sodas. Try not to give him or her any medicine that has a stimulant at bedtime. This includes cough medicines and decongestants.

It is important to make sure that your child gets enough sleep and sleeps well. The value of sleep can be measured by your child's smiling face, happy nature and natural energy. A tired child may have development or behavior problems. A child's sleep problems can also cause unnecessary stress for you and the other members of your family.







More information about children and sleep is available from the AASM at sleepeducation/Topic.aspx?id=8.



The annual SLEEP meeting (9-12 June, 2008) brings together an international body of 5,000 leading researchers and clinicians in the field of sleep medicine to present and discuss new findings and medical developments related to sleep and sleep disorders.



More than 1,000 research abstracts will be presented at the SLEEP meeting, a joint venture of the AASM and the Sleep Research Society. The three-and-a-half-day scientific meeting will bring to light new findings that enhance the understanding of the processes of sleep and aid the diagnosis and treatment of sleep disorders such as insomnia, narcolepsy and sleep apnea.



SleepEducation, a patient education Web site created by the AASM, provides information about various sleep disorders, the forms of treatment available, recent news on the topic of sleep, sleep studies that have been conducted and a listing of sleep facilities.


Mental Illness In USA Widespread And Commonly Untreated

Nearly one fifth of all adults in the United States say they had a mental illness during the preceding 12 months. Of serious concern is that only 37% got any professional medical help, according to a new report issued by the Substance Abuse and Mental Health Services Administration (SAMHSA). The report also revealed that there are 4.4 million Americans with a "serious mental health illness" who are walking around untreated.


The authors revealed that:

19.9% of the people surveyed said they had had a mental illness during the twelve months before their interview
4.8% reported having a serious mental health illness during the same time frame; nationally, this totals 11 million people

A serious mental illness is one that makes at least one major activity in life extremely difficult or impossible to do, according to SAMHSA.


Of the 8.4 million adult Americans who thought seriously about committing suicide during the preceding twelve months, 2.2 million went further and actually made some plans, and one million attempted suicide, the report informs.


Approximately 19% of those with a mental illness were also found to have a substance abuse disorder. 25.7% of individuals with a serious mental illness also have a substance abuse disorder.


Pamela S. Hyde, J.D., who works in SAMHSA, said:
"Too many Americans are not getting the help they need and opportunities to prevent and intervene early are being missed. The consequences for individuals, families and communities can be devastating. If left untreated mental illnesses can result in disability, substance abuse, suicides, lost productivity, and family discord. Through health care reform and the Mental Health Parity and Addiction Equity Act we can help far more people get needed treatment for behavioral health problems."
Mental illness is more common among people who are unemployed (27%) compared to those in a full time occupation (17.1%). The authors also found that mental illness among females (23.8%) is significantly more common than males (15.6%).


People with severe mental illness symptoms are more likely to be young adults up to 25 years of age (30% of those with severe symptoms) compared to people aged 50+ (13.7%).


62.1% of those with a mental illness did not receive any medical help, compared to 39.8% of those with severe symptoms who also didn't.


"Results from the 2009 National Survey on Drug Use and Health: Mental Health Findings"


Written by Edward Pritchard



Postnatal Depression Can Be Effectively Treated And Possibly Prevented

Health visitors can be trained to identify women with postnatal depression and offer effective treatment, while telephone peer support (mother to mother) may halve the risk of developing postnatal depression, suggests research published on bmj today.


About 13% of women experience postnatal depression in the year following the birth of their child. But postnatal depression is frequently undetected and untreated, often because of poor recognition of symptoms, unawareness of treatment options or fear of stigmatisation.


Antidepressants have been shown to be an effective treatment for postnatal depression, but many women are reluctant to take drugs, especially when breast feeding. Psychological therapies may provide an alternative treatment, but their effectiveness is unclear.


In one of the largest trials of postnatal depression, Dr Jane Morrell and colleagues analysed whether psychological interventions were effective in treating the symptoms of postnatal depression. Over 4,000 mothers from 101 general practices in England consented to take part. Practices were randomised so women received either a cognitive behavioural approach or a person centred approach from specially trained health visitors or health visitor usual care.


Health visitors in the intervention group were trained to identify depressive symptoms and deliver cognitive behavioural or person centred sessions for an hour per week for up to eight weeks. Validated scales were used to assess depressive symptoms among the mothers. A threshold score of 12 or more identified women with symptoms of depression. Participants were followed up for 18 months and assessed every six months using a postal questionnaire.


At both six months and 12 months postnatally, the mothers who received care from the specially trained health visitors showed significantly greater reductions in depressive symptoms than those who received health visitor usual care. Mothers in the intervention group with depressive symptoms at six weeks were 40% less likely to have depressive symptoms at six months than those receiving health visitor usual care.


The researchers found no benefit of one psychological approach over the other.


In a second study, Dr Cindy-Lee Dennis and colleagues from Canada examined the effectiveness of telephone based peer support to prevent postnatal depression in high risk women.


After web-based screening of more than 21,000 women from seven health regions in Ontario, Canada, 701 were identified at high risk of postnatal depression and randomised to receive standard postnatal care or standard care and the support of a peer volunteer (who had experienced postnatal depression themselves).



Mothers who received peer support had half the risk of developing postnatal depression at 12 weeks after birth than those in the control group. Mothers were receptive to receiving telephone-based peer support and over 80% said they were satisfied with their experience and would recommend this support to a friend.


Women and family members need to be educated about postnatal depression so they can recognise the symptoms, and treatment needs to be convenient and accessible to new mothers, says Dr Cindy-Lee Dennis in an accompanying editorial.


She calls for a coordinated multidisciplinary approach to identify postnatal depression involving all health professionals who come into contact with new mothers including midwives, doctors, nurses and health visitors.


"Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care."

BMJ Online

Click here to view article online.


"The effect of peer support on the prevention of postnatal depression among high risk women: randomised controlled trial."

BMJ Online

Click here to view article online.

FDA Approves Wellbutrin XL(TM) for Major Depressive Disorder

Contact: Holly Russell

919-483-2839

Cooney Waters Group, Inc.


New, once-daily antidepressant


Research Triangle Park, NC (USA) - GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Wellbutrin XL™ (bupropion hydrochloride extended-release tablets) for the treatment of major depressive disorder in patients 18 and older.


The new once-daily medication will offer patients an effective and convenient option to treat their depression, with a low risk of sexual side effects and weight gain.


Sexual function and weight change are important considerations in selecting antidepressant therapy, as they may be a side effect of the medication or a symptom of the depression itself. GlaxoSmithKline expects Wellbutrin XL to be available in pharmacies by mid-September.


'Approximately 14 million adults in the U.S. suffer from depression, and while the number of available treatments has increased in the past decade, some antidepressant medications have left patients coping with other problems, such as side effects, which may include sexual dysfunction and weight change,' said Anita Clayton, M.D., Professor of Psychiatry at the University of Virginia Health System.


'Wellbutrin XL is a long-awaited treatment option because it offers a low risk of sexual side effects and weight gain - with the convenience of once-daily dosing.'



Wellbutrin XL tablets have a two-layered coating designed to release drug slowly in the body. GlaxoSmithKline licensed this once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001.


Wellbutrin XL will be available in two strengths, 150 mg and 300 mg, to allow for dosing flexibility. The usual target dose is 300 mg given once daily - initiated at 150 mg/day and then increased to 300 mg/day as early as day four, if adequately tolerated. The maximum total daily dose of Wellbutrin XL is 450 mg.



'Wellbutrin XL builds on a strong foundation. Through the first half of 2003, our twice-daily formulation, Wellbutrin SR®, has remained the number one prescribed antidepressant among U.S. psychiatrists,' said Chris Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline.


'Yet we know that for many doctors twice-daily dosing is a major prescribing barrier. We are confident that the convenient once-daily dosing of Wellbutrin XL will be a welcome improvement for patients coping with depressive illness and for the physicians who are treating them.'



HOW WELLBUTRIN XL WORKS



Wellbutrin XL is the first and only once-daily norepinephrine and dopamine reuptake inhibitor (NDRI) for the treatment of depression in adults.


The active ingredient in Wellbutrin XL - bupropion hydrochloride - is believed to act upon norepinephrine and dopamine, two chemicals in the brain known to help regulate different aspects of mood, cognition, and behavior. Imbalances in these brain chemicals are associated with depressed mood and other symptoms of depression.















Bupropion has no clinically significant impact on serotonin, a third brain chemical involved in mood regulation.



'In my clinical practice of treating patients with depression, sexual problems and weight change may be related to the depression itself, or these problems may arise as side effects of the antidepressant treatment,' said James F. Pradko, M.Sc., M.D. a practicing physician and the director of the Bay Pointe Depression Clinic in Detroit MI.


'In either case, sexual function and weight issues relating to depression should be addressed and can have an impact on a patient's treatment and well-being.'



CLINICAL HIGHLIGHTS



The approval of Wellbutrin XL was based on bioequivalence to Wellbutrin® Tablets (the immediate-release formulation of bupropion). Wellbutrin XL has also been proven bioequivalent to Wellbutrin SR® Tablets (the sustained-release formulation of bupropion).



The efficacy of bupropion in the treatment of a major depressive episode was established using the immediate-release formulation in two four-week controlled trials of inpatients and one six-week controlled trial of outpatients who met criteria for major depression.


The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks was established with the sustained-release formulation in a placebo-controlled trial. Bupropion has also been shown to be effective in preventing relapse of depression.

In other clinical studies, the active ingredient in Wellbutrin XL has proven comparable to Zoloft®* in treating moderate to severe recurrent major depression.



SAFETY INFORMATION



Wellbutrin XL has been proven bioequivalent to both Wellbutrin® Tablets and Wellbutrin SR® tablets. Given that there are multiple formulations of bupropion, familiarity with the different names and dosing schedules is important to avoid dosing errors.



Placebo-controlled trials of Wellbutrin SR show it to be generally well tolerated. Adverse events reported in at least 10 percent of patients treated with Wellbutrin SR 300 mg/day or 400 mg/day and at a rate at least twice that of placebo were dry mouth, nausea, insomnia, dizziness, weight loss, and pharyngitis. Similar adverse events would be expected with Wellbutrin XL.



Wellbutrin XL is contraindicated in patients who have or have had a seizure disorder, patients being treated with Zyban® (bupropion hydrochloride) Sustained-Release Tablets or Wellbutrin SR® or any other medications that contain bupropion, patients who have or had bulimia or anorexia nervosa, patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines), and patients taking monoamine oxidase (MAO) inhibitors.



In treating depression, physicians should be aware that Wellbutrin XL™ is associated with a risk of seizures which is dose-related.


While Wellbutrin XL has not been formally evaluated in clinical trials, its incidence of seizure may be similar to that of the immediate-release and the sustained-release formulations of bupropion, since it has demonstrated bioequivalence to both.

At doses of up to 300 mg/day of the sustained-release formulation (Wellbutrin SR®), the incidence of seizure is approximately 0.1 percent.


At doses of 300 mg/day to 450 mg/day of the immediate-release (Wellbutrin), the incidence of seizure is approximately 0.4 percent. To reduce the risk of seizures, refer to the Warnings section of the Prescribing Information for patient selection considerations, including concomitant medications and dosing recommendations.



The weight loss potential of Wellbutrin XL should be considered if weight loss is a major presenting sign of the depressive illness.



When treating patients with severe hepatic cirrhosis, extreme caution should be exercised and a reduced dosage and/or frequency is required to avoid accumulation.



ABOUT GLAXOSMITHKLINE



GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GlaxoSmithKline has U.S. operations in Philadelphia and Research Triangle Park, N.C.



For full prescribing information or product photo, please contact Holly Russell at 919-483-2839.



* Zoloft (sertraline HCl) is a registered trademark of Pfizer Inc.


View drug information on Zoloft.

Study Finds Lesser Conditions A Stepping Stone To Major Depression

Elderly patients with lesser versions of depression, a group many times larger than those with major depression, are more than five times as likely as healthy patients to descend into major depression within one year, according to a study published today in the Annals of Internal Medicine. The study's authors believe that perhaps millions of elderly patients who do not meet the criteria for a diagnosis of major depression are indeed depressed, suffering and not being treated for it.



Researchers are focusing on depression in elderly patients because the number of persons aged 65 years or older (about 36 million) is expected to double in the next 25 years, with a third of them expected to struggle with a mental disorder at some point. While major depression among the elderly is an important problem, it has overshadowed related disorders that are less serious, but that leave many more people with suffering from painful emotions, disinterest in their surroundings, and thoughts of worthlessness. As a result, this group is more functionally disabled, less able to feed and groom themselves, or to go shopping.



The current study is the first to carefully reexamine the definitions of certain depression types in older patients seen in primary care settings, and to compare outcomes in different types of depression. According to the Diagnostic and Statistical Manual for Mental Disorders 4th Edition (DSM-IV), minor depression is officially defined using the exact same symptoms as major depression, but including fewer of them. To be precise, persons suffering from minor depression experience 2 to 4 symptoms of depression for most of the day nearly every day, while those with major depression experience five or more symptoms. Patients with the same symptoms, but experiencing them less frequently - perhaps only several days per week, or for only a few hours each day -- fall within the "subsyndromal" depression category.



Among patients in the current study, 20 percent were found to meet the criteria for minor or subsyndromal depression, compared to just five percent that met the definition of major depression. Projecting the percentages out to the U.S. population over aged 65, researchers estimate that about 7 million experience minor or subsyndromal depression, often undiagnosed and untreated, compared to 1.75 million senior citizens with major or so-called clinical depression.



"Our study makes the point that the lines drawn between major and minor depression, while useful in some ways, are arbitrary, and may need to be redrawn to put an end to a great deal of suffering in this country," said Jeffrey M. Lyness, M.D., director of the Program in Geriatrics and Neuropsychiatry at the University of Rochester Medical Center, and lead author of the article. "The less severe the depression, the less it has been studied, regardless of how significant its impact might be."
















Study Details



The current study followed 622 patients who were at least 60 years of age and came in for treatment in primary care practices in greater New York City, Philadelphia and Pittsburgh. The current study sought to measure minor depression, not by studying patients that report to psychiatrist's office, but instead by measuring depression among those who visited their primary care doctors' offices. Most elderly persons never see mental a health specialist, but instead may tell their primary care physician about feeling down or nervous or otherwise unwell during a regular check-up.



Of the 441(70.9%) patients who completed one year of follow-up, 122 had major depression, 205 had minor or subsyndromal depression, and 114 did not have depression at the beginning of the study. One year after a baseline evaluation, data were collected using standard questionnaires and measurements of depression (e.g., Hamilton Depression Rating Scale).



The study found that patients with minor or subsyndromal depression were five and one-half times more likely to be diagnosed with major depression within a year than those who were not depressed at the start of the study. The group with minor and subsyndromal depression also suffered greater functional disability at one year than patients without depression, although not as severe as those with major depression. As shown in other studies, the level of a patient's medical illness to start with (medical burden) and patients' beliefs about their health and support from others such as families or friends were significant, independent predictors of depression outcome.



Beginnings of A Solution



Lyness has also co-authored a separate study, now in press in The American Journal of Psychiatry, which may hold part of the answer for these oft-neglected patients with minor and subsyndromal depression. In short, the second study, a statistical analysis of previously published clinical studies, found that patients with less severe forms of depression may on average experience 40 percent more improvement from psychotherapy (i.e., counseling) than from treatment with antidepressant drugs. In addition, a greater proportion of patients receiving psychotherapy improved than did those receiving drug treatment, Lyness said.



"There is an urgent need for all of us in the field to redraw the definitions and standards in minor and subsyndromal depression, but that will not happen until we prove what works for these patients in particular, as opposed to what works for patients with major depression," Lyness said. "In the near future we will seek to identify those patients most in need and most likely to respond to specific therapy or medications. To do so, my colleagues and I are currently analyzing information collected over the past five years from over 750 older persons in the Rochester area."







Contact: Greg Williams

Greg_Williamsurmc.rochester

University of Rochester Medical Center

Northstar Neuroscience Receives FDA Approval For A Clinical Study Of Its Cortical Stimulation System For The Treatment Of Major Depressive Disorder

Northstar Neuroscience, Inc. (NASDAQ: NSTR) today announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of a second clinical study of its Renova™ Cortical Stimulation System for the treatment of major depressive disorder (MDD). With this approval, the Company expects to begin enrolling patients into its PROSPECT II study this quarter, with preliminary results anticipated during the second half of 2009.


The PROSPECT II study is a prospective, double-blinded, sham-controlled study designed to build on the positive safety profile and promising efficacy observed in the PROSPECT I feasibility trial. The trial will be conducted at up to six investigational sites and will include up to 24 subjects.


"Major depressive disorder affects millions of people who are not adequately treated today and who suffer greatly. Targeted stimulation of the cerebral cortex has shown promise in relieving depressive symptoms where drugs and other therapies have not been effective," said John Bowers, President and CEO of Northstar Neuroscience. "This is an important milestone for our depression program, and we are excited to move forward with our clinical collaborators to begin study enrollment."


"Cortical stimulation represents a new approach to treat depression," added Dr. Brian Kopell, Northstar's Vice President of Medical Affairs. "Increasing evidence points to disordered neural networks in the brain as an underlying cause of depressive symptoms. We believe that we can influence these networks with electrical stimulation without placing electrodes deep within brain tissue. This technology has the potential to offer an alternative treatment to many desperate individuals who currently have exhausted conventional options for the treatment of major depressive disorder."


ABOUT MAJOR DEPRESSIVE DISORDER


Among all medical illnesses, major depression is the leading cause of disability in the U.S. More than 21 million Americans suffer from some kind of mood disorder, nearly 15 million of whom suffer from major depressive disorder. Major depressive disorder is a devastating illness that causes significant changes to a person's thoughts, behavior, mood, activity and physical health. MDD takes a toll on millions of families and ranks among the top three workplace issues, following only family crisis and stress.


ABOUT CORTICAL STIMULATON


Cortical stimulation involves a neurosurgical procedure to place an electrode over the outermost layer of the brain, called the cerebral cortex. The electrode is then connected via a lead wire to a neurostimulator in the patient's chest. The pacemaker-sized neurostimulator and lead wire are implanted under the skin and are capable of continuously delivering electrical stimulation to the brain.


ABOUT NORTHSTAR NEUROSCIENCE


Northstar Neuroscience, Inc. is a medical device company focused on developing and commercializing innovative neuromodulation therapies to restore function and quality of life for people suffering from neurological diseases and disorders. For more information, visit northstarneuro


CAUTION: Investigational Device. Limited by Federal Law (U.S.) to investigational use.


This release contains information about management's view of our future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with our ability to complete our ongoing or any future clinical trials, or decisions whether to conduct additional clinical trials, delays in conducting or completing any of our clinical trials, the results of any of our clinical trials, including the results of our PROSPECT I and PROSPECT II clinical trials, and results from our current or previous trials may not be indicative of success in any later clinical trials. We encourage you to review other factors that may affect our future results in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 5, 2008 and in other documents and reports we file periodically with the Securities and Exchange Commission.


View drug information on Renova.

Infants Exposed To Antidepressants In Utero At Risk Of Developing Neonatal Abstinence Syndrome, Study Says

Infants exposed to antidepressants in utero are at risk of developing neonatal abstinence syndrome, according to a study published on Monday in the Archives of Pediatrics and Adolescent Medicine, Reuters reports. According to Reuters, NAS is defined as a type of withdrawal, distinguished by high-pitched crying, tremors and sleeping problems. Gil Klinger of Schneider Children's Medical Center of Israel and colleagues looked at 60 infants who were exposed to antidepressants in utero and 60 who were not exposed (Reuters, 2/6). Of the 60 exposed infants, eight exhibited severe NAS symptoms and 10 exhibited mild NAS symptoms. All of the 60 infants who were not exposed to antidepressants were designated as "normal" (Klinger et al., Archives of Pediatrics and Adolescent Medicine, February 2006). According to researchers, NAS does not need treatment, but the "long-term effects of in utero exposure to [antidepressants] have not been demonstrated clearly" (Bakalar, New York Times, 2/7). The researchers also wrote, "Infants exposed to [antidepressants] should be closely monitored after birth by using a standardized protocol for a minimum of 48 hours," adding that infants, especially those who experience severe symptoms, should receive follow-up care to evaluate possible long-term effects of NAS (Reuters, 2/6).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

During Fertility Treatment Anxiety And Depression Do Not Affect Pregnancy And Treatment Cancellation Rates

Anxiety and depression before and during fertility treatment does not affect the likelihood of a woman becoming pregnant or of her cancelling her treatment, according to a study published in Europe's leading reproductive medicine journal, Human Reproduction [1] on Thursday 29 January.



Dr Bea Lintsen, a physician at the Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre (The Netherlands), and her colleagues used questionnaires to assess the levels of psychological distress in 783 women at two points before and during fertility treatment. Results from the 421 women who completed both questionnaires showed that levels of depression or anxiety either before or during fertility treatment had no influence over cancellation rates and did not predict pregnancy rates either.



Until now, studies of the links between anxiety and depression and the success of fertility treatment have been inconclusive. Dr Lintsen believes hers is the largest prospective study yet to look at the influence of distress on the outcome of a first IVF or ICSI treatment, and that the findings are reliable. However, she and her colleagues say the associations between psychological factors and pregnancy rates after IVF are complex and require further research into mediating factors such as lifestyle and sexual behaviour.







[1] Anxiety and depression have no influence on the cancellation and pregnancy rates of a first IVF or ICSI treatment. Human Reproduction. Published online under advance access. doi:10.1093/humrep/den491.



Human Reproduction is a monthly journal of the European Society of Human Reproduction and Embryology (ESHRE), and is published by Oxford Journals, a division of Oxford University Press.



ESHRE's website is: eshre



Abstracts of other papers in ESHRE's three journals - Human Reproduction, Molecular Human Reproduction and Human Reproduction Update - can be accessed from oxfordjournals/eshre.


Ritalin-style Drug Set For Wider Role In Adult Mental Illness

A significant number of adults with unresolved depression, anxiety or addiction may actually have Attention Deficit Hyperactivity Disorder (ADHD), a condition that has been widely considered to resolve in late adolescence.



Armed with the correct diagnosis, adult ADHD sufferers could soon be prescribed Ritalin-style stimulant medications for a range of mental health problems that are not usually associated with the disorder, the Royal College of Psychiatrists' annual meeting was told on Friday 4 July.



Stimulant medication is currently only licensed for children with ADHD. However, the National Institute for Health and Clinical Excellence (NICE) is expected to recommend that this class of drug can be prescribed adults with ADHD in September 2008 - following the recognition that the condition persists into adulthood in about 20 per cent of cases diagnosed in childhood.



But while ADHD symptoms in children include inattentiveness, hyperactivity and impulsiveness, the condition in adults is associated with a much wider range of co-existing mental health problems.



Professor Phillip Asherson, professor of molecular psychiatry at the Institute of Psychiatry, told the meeting: "Most frequently, adults with ADHD are diagnosed with chronic and persistent depression and anxiety, difficult-to-treat alcohol and drug addiction and personality disorders.



"We don't yet know whether these co-existing disorders are separate problems or whether these people are actually suffering from a form of ADHD that is presenting in a different way from the normal symptoms. It could be that many people are being diagnosed as having a separate disorder when in fact they have got ADHD."



Currently, clinicians are wary of using stimulant medication in adults, as the only group of drugs that are licensed only for use in children. However, Professor Asherson said: "This is likely to change once the new NICE guidelines are launched in September."



Meanwhile, Professor Asherson is about to embark on a major study to identify adults with ADHD who present in GP surgeries and addiction centres. "We have no idea as yet whether these problems will respond to stimulant medication. If they do, then this type of drug could provide effective treatment for a significant number of adults who currently have unresolved mental health problems," he said.


Reference

The Annual Meeting of the Royal College of Psychiatrists, Imperial College, London,
1 - 4 July 2008



The Royal College of Psychiatrists

rcpsych.ac.uk

Female Smokers At Greater Risk For Depression, Australian Study Reveals

A new study reveals that women who smoke are at greater risk of developing major depressive disorder. The study has been published today the British Journal of Psychiatry.



Australian researchers from the University of Melbourne and Geelng's Barwon Health assessed a group of 1043 Australian women, whose health had been monitored for a decade as part of the Geelong Osteoporosis Study.



On their ten year follow up participants were given an additional test of a psychiatric assessment.



"It was at this point we were able to determine if depression had developed and investigate whether or not smoking pre-dated the onset of depression" said University of Melbourne researcher, Associate Professor Julie Pasco, who led the study within the Clinical and Biomedical Sciences at Barwon Health.



Results revealed that women with depression were more likely to have been smokers than those without depression. Compared with non-smokers, the likelihood for developing depression more than doubled for heavy smokers (those who smoked more than 20 cigarettes a day).



The researchers also examined longitudinal data to determine the risk of women developing a new major depressive disorder over time.



A total of 671 women with no history of major depressive disorders were studied. Of the 87 women who were smokers, 13 (15%) went on to develop major depressive disorder.



However, among 584 non-smokers, just 38 (6.5%) developed major depressive disorder during a decade of follow-up.



"This shows us that non smokers were at lower risk for developing major depressive disorder, suggesting that smoking may play a role in the development of the disease in women, " Associate Professor Pasco said.



Previous research has shown that smoking is a risk factor for depression. There is also increasing evidence that smoking may aggravate mental illness or contribute to its onset.



However, most previous studies have involved short time frames, and this study is the first to investigate smoking using longitudinal data that extends over a ten-year period.



The researchers observed that depression is a leading contributor to the global disease burden, and called for greater efforts to encourage smokers to quit.






Link Between Antidepressant Use And Thicker Arteries

Antidepressant use has been linked to thicker arteries, possibly contributing to the risk of heart disease and stroke, in a study of twin veterans. The data is being presented Tuesday, April 5 at the American College of Cardiology meeting in New Orleans.



Depression can heighten the risk for heart disease, but the effect of antidepressant use revealed by the study is separate and independent from depression itself, says first author Amit Shah, MD, a cardiology fellow at Emory University School of Medicine. The data suggest that antidepressants may combine with depression for a negative effect on blood vessels, he says. Shah is a researcher working with Viola Vaccarino, MD, PhD, chair of the Department of Epidemiology at Emory's Rollins School of Public Health.



The study included 513 middle-aged male twins who both served in the U.S. military during the Vietnam War. Twins are genetically the same but may be different when it comes to other risk factors such as diet, smoking and exercise, so studying them is a good way to distill out the effects of genetics, Shah says.



Researchers measured carotid intima-media thickness - the thickness of the lining of the main arteries in the neck - by ultrasound. Among the 59 pairs of twins where only one brother took antidepressants, the one taking the drugs tended to have higher carotid intima-media thickness (IMT), even when standard heart disease risk factors were taken into account. The effect was seen both in twins with or without a previous heart attack or stroke. A higher level of depressive symptoms was associated with higher IMT only in those taking antidepressants.



"One of the strongest and best-studied factors that thickens someone's arteries is age, and that happens at around 10 microns per year," Shah says. "In our study, users of antidepressants see an average 40 micron increase in IMT, so their carotid arteries are in effect four years older."



Antidepressants' effects on blood vessels may come from changes in serotonin, a chemical that helps some brain cells communicate but also functions outside the brain, Shah says. The most commonly prescribed antidepressants are selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac), which increase the level of serotonin in the brain. Other types of antidepressants also affect serotonin levels, and antidepressants can act on other multi-functional brain chemicals such as norepinephrine.



In the study, researchers saw higher carotid IMT in both participants who used SSRIs (60 percent of those who took antidepressants) and those who used other types of antidepressants.



Most of the serotonin in the body is found outside the brain, especially in the intestines, Shah notes. In addition, serotonin is stored by platelets, the cells that promote blood clotting, and is released when they bind to a clot. However, serotonin's effects on blood vessels are complex and act in multiple ways. It can either constrict or relax blood vessels, depending on whether the vessels are damaged or not.



"I think we have to keep an open mind about the effects of antidepressants on neurochemicals like serotonin in places outside the brain, such as the vasculature. The body often compensates over time for drugs' immediate effects," Shah says. "Antidepressants have a clinical benefit that has been established, so nobody taking these medications should stop based only on these results. This isn't the kind of study where we can know cause and effect, let alone mechanism, and we need to see whether this holds up in other population groups."


Depression And Back Pain

It is well documented that physical pain can lead to feelings of depression, but a new study from the University of Alberta shows the reverse can be true, as well.


Dr. Linda Carroll, a professor in the U of A Department of Public Health Sciences, led the study that shows depression is a risk factor for onset of severe neck and low back pain. The study is published in the journal Pain.



Carroll and her colleagues followed a random sample of nearly 800 adults without neck and low back pain and found that people who suffer from depression are four times as likely to develop intense or disabling neck and low back pain than those who are not depressed.



'We've known for a long time that pain can lead to depression, and now we're finding that each is a risk for the other,' Carroll said.

'Both conditions are recurrent, that is, they can both come and go; and both are very common--in fact, only 20 per cent of the population has not experienced any neck or low back pain in the past six months--so it's important to try to deal with these conditions before they become troublesome and lead to a vicious cycle.'



Carroll is now interested to figure out why the two conditions are commonly related, and she is focusing her research on the coping methods of people with depression, a condition researchers have long known to be associated with physical ailments.



There are two broad ways people can cope with pain, Carroll said. One is to be passive, which entails such things as withdrawing from activities because of the pain or wishing for better pain medication. The other is to be active, which entails getting exercise and staying busy, for example.



'We're wondering if depression leads people to cope passively when they experience the kinds of mild pain episodes that most of us are periodically subject to. This in turn may increase the likelihood that pain will become a problem in someone's life. The next step is to answer this question,' added Carroll, whose research is sponsored by the Alberta Heritage Foundation for Medical Research.



Dr. Carroll can be reached at (780) 492-9767 or lcarrollualberta.ca



Contact: Ryan Smith

ryan.smithualberta.ca

780-492-0436

University of Alberta

Increased Risk Of Gastric Bleeding From Antidepressants And Painkiller Combination

New research shows that selective serotonin reuptake inhibitors (SSRIs), a group of drugs commonly used to treat depression, may double the risk of gastrointestinal bleeding, according to researchers from Wake Forest University School of Medicine and colleagues. When the drugs are taken with aspirin and other similar pain medications, the risk is more than 600 percent higher.


"Clinicians who prescribe these medications should be aware of the potential risk and may need to consider alternatives," said Sonal Singh, M.D., senior researcher and an assistant professor of internal medicine. "In addition, regulatory authorities should consider revising existing package inserts to highlight the magnitude of the risk."


The research was reported online this month in Alimentary Pharmacology & Therapeutics. Emerging evidence has shown that SSRIs may be associated with bleeding of the lining of the digestive tract including the esophagus, stomach or upper part of the small intestine, which together are called the upper gastrointestinal (GI) tract. Upper gastrointestinal bleeding may be potentially serious and require hospitalization for blood transfusions and other treatments.


The drugs are widely used to treat depression, panic disorder and obsessive-compulsive disorder. The researchers undertook the study because of a lack of information on the exact magnitude of the risk. They also looked at the effects of taking SSRIs at the same time as non-steroidal anti-inflammatory drugs (NSAIDs), which are also associated with upper GI bleeding. NSAIDs include prescription medications such as Celebrex® and over-the-counter drugs such as aspirin and Aleve®.


The researchers pooled data from four studies involving 153,000 patients, which allowed them to detect effects that might not show up in the individual studies. They found patients taking SSRIs were nearly twice as likely to develop upper GI bleeding than patients not taking the drugs. When the patients also took NSAIDs, the risk of upper gastrointestinal bleeding was six times higher than in patients taking neither medication.
The authors said the combined use of NSAIDs and SSRIs may have a synergistic effect, which results in the elevated risk of bleeding beyond that seen with each agent alone.


"While the risk to an individual may increase by only a small amount, the impact to the general population is likely to be substantial because of the large numbers of people who use these drugs," said Singh.
He said that depressed, older adults may be most vulnerable because they are more likely to have conditions such as osteoarthritis that require the use of NSAIDs.


Based on their findings, the authors estimate that for every 411 patients over age 50 taking SSRIs, one is likely to develop upper GI bleeding requiring hospital admission. In patients taking both SSRIs and NSAIDs, one out of 82 would be expected to develop the problem.















"We estimate that roughly 18,000 additional cases of upper GI bleeding occurred in the United States and United Kingdom in 2003 as a result of taking SSRIs," said Singh.


In addition to the clinical studies, the researchers analyzed 101 reports on adverse effects submitted to the Canadian Adverse Events Database and the U.S. Food and Drug Administration's Adverse Event Reporting System. They found that bleeding associated with SSRI use occurred after a median of 25 weeks on the drugs. About 67 percent of those patients were also taking NSAIDs. The adverse reaction was not limited to the elderly, with 38 percent of cases occurring in patients below the age of 60.


"These findings emphasize the importance of clinicians taking a detailed gastrointestinal history from patients and targeting the use of SSRIs to patients who are at relatively low risk for upper GI bleeding," said Singh.


The research did not distinguish between specific drugs and whether one was associated with more bleeding than another. However, previous studies have shown that paroxetine (Paxil®), sertraline (Zoloft®) and fluoxetine (Prozac®) are most often associated with abnormal bleeding. Singh said future research should address the question of which specific drugs and combinations of drugs are associated with the highest risk.
Singh's co-researchers were Apurva Trivedi, M.D., with Wake Forest, and Yoon K. Loke, M.D., lead author, with the University of East Anglia, Norwich, United Kingdom.


Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university's School of Medicine. The system comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of "America' s Best Hospitals by U.S. News & World Report".

wfubmc


View drug information on Paxil CR; Prozac Weekly; Zoloft.

80 Percent Of Cases Of Postnatal Depression Predicted By New Method

Worldwide, 13% of women who give birth suffer from postnatal depression, which causes a significant deterioration in a mother's quality of life and her ability to care for her baby. Now, Spanish researchers have developed a model to diagnose this illness with a predictive power of 80% - the best result to date for this kind of depression.



"Early diagnosis of postnatal depression would make it possible to intervene to prevent it from developing among women at risk", Salvador Tortajada, lead author of the study and a researcher at the Polytechnic University of Valencia (UPV), tells SINC.



The experts studied data on 1,397 Spanish women who gave birth between December 2003 and October 2004 in seven hospitals in Spain, and devised various models that can predict - with an 80% success rate - which mothers run the risk of developing depression during the first weeks after giving birth.



This study, which is the first of its kind in Spain and has been published recently in the journal Methods of Information in Medicine, gives the best results to date in terms of predicting this illness. "Now it needs clinical evaluation, and for psychiatrists to start to test it directly on patients in order to study the true potential of these tools", says Tortajada.



The researchers used artificial neuronal networks and extracted a series of risk factors highlighted in previous studies - the extent of social support for the mother, prior psychiatric problems in the family, emotional changes during the birth, neuroticism and polymorphisms in the serotonin transport gene (genes with high levels of expression lead to an increased risk of developing the illness).



They also discovered two protection factors that reduce the risk of depression - age (the older the woman the lower her chance of depression), and whether or not a woman has worked during pregnancy (which reduces the risk). The researcher points out that: "it can be seen that these factors are relevant in the neuronal networks, but not by using other statistical methods". The path is now clear for future studies to corroborate these findings.



However, many studies have shown that between 10 and 15% of women who give birth suffer from depression, normally between the second and third month after having given birth. This illness affects the patient's emotional and cognitive functions (in extreme cases leading to suicidal tendencies), and may have serious knock-on effects on the child's future development.


Cannabis Study Finds 'A Double-Edged Sword'

A new neurobiological study has found that a synthetic form of THC, the active ingredient in cannabis, is an effective anti-depressant at low doses. However, at higher doses, the effect reverses itself and can actually worsen depression and other psychiatric conditions like psychosis.



The study, published in the October 24 issue of The Journal of Neuroscience, was led by Dr. Gabriella Gobbi of McGill University and Le Centre de Recherche Fernand Seguin of H??pital Louis-H. Lafontaine, affiliated with l'Universit?© de Montr?©al. First author is Dr. Gobbi's McGill PhD student Francis Bambico, along with Noam Katz and the late Dr. Guy Debonnel* of McGill's Department of Psychiatry.



It has been known for many years that depletion of the neurotransmitter serotonin in the brain leads to depression, so SSRI-class anti-depressants like Prozac and Celexa work by enhancing the available concentration of serotonin in the brain. However, this study offers the first evidence that cannabis can also increase serotonin, at least at lower doses.



Laboratory animals were injected with the synthetic cannabinoid WIN55,212-2 and then tested with the Forced Swim test -- a test to measure "depression" in animals; the researchers observed an antidepressant effect of cannabinoids paralleled by an increased activity in the neurons that produce serotonin. However, increasing the cannabinoid dose beyond a set point completely undid the benefits, said Dr. Gobbi.



"Low doses had a potent anti-depressant effect, but when we increased the dose, the serotonin in the rats' brains actually dropped below the level of those in the control group. So we actually demonstrated a double effect: At low doses it increases serotonin, but at higher doses the effect is devastating, completely reversed."



The anti-depressant and intoxicating effects of cannabis are due to its chemical similarity to natural substances in the brain known as "endo-cannabinoids," which are released under conditions of high stress or pain, explained Dr. Gobbi. They interact with the brain through structures called cannabinoid CB1 receptors. This study demonstrates for the first time that these receptors have a direct effect on the cells producing serotonin, which is a neurotransmitter that regulates the mood.



Dr. Gobbi and her colleagues were prompted to explore cannabis' potential as an anti-depressant through anecdotal clinical evidence, she said. "As a psychiatrist, I noticed that several of my patients suffering from depression used to smoke cannabis. And in the scientific literature, we had some evidence that people treated with cannabis for multiple sclerosis or AIDS showed a big improvement in mood disorders. But there were no laboratory studies demonstrating the anti-depressant mechanism of action of cannabis."



Because controlling the dosage of natural cannabis is difficult -- particularly when it is smoked in the form of marijuana joints -- there are perils associated with using it directly as an anti-depressant.



"Excessive cannabis use in people with depression poses high risk of psychosis," said Dr. Gobbi. Instead, she and her colleagues are focusing their research on a new class of drugs which enhance the effects of the brain's natural endo-cannabinoids.



"We know that it's entirely possible to produce drugs which will enhance endo-cannabinoids for the treatment of pain, depression and anxiety," she said.







*Dr. Guy Debonnel, a highly respected depression researcher who had been at McGill University since 1988, passed away unexpectedly at the age of 57 in November, 2006.


Depressed Fathers Can Affect Children's Health And Development

41% of depressed fathers were found have spanked their child compared to 13% of non-depressed dads, researchers from the University of Michigan in Ann Arbor revealed in the journal Pediatrics.


R. Neal Davis, MD, MSc, and team gathered information on 1,746 dads with 1-year-old children from the Fragile Families and Child Wellbeing Study.


A positive parenting behavior includes playing games, reading stories, and singing songs with a child at least 3 days in a typical week. Negative parenting behaviors include spanking.


They used the World Health Organization Composite International Diagnostic Interview Short Form to assess depression in fathers.


They found that approximately 7% of all dads were suffering from depression.


They also found that a father with depression is considerably less likely to read regularly to his child.


On the other hand, they report that depressed and non-depressed dads were just as likely to play games, sing or talk to their children. The researchers believe these activities are more routinely performed by fathers than reading.


77% of fathers with depression said they had talked to their child's pediatrician during the previous twelve months. Therefore, doctor's visits might be an ideal opportunity to talk about specific parenting behaviors (screening for depression) and refer dads for appropriate therapy.


"Fathers' Depression Related to Positive and Negative Parenting Behaviors With 1-Year-Old Children"

R. Neal Davis, MD, MSc, Matthew M. Davis, MD, MAPP, Gary L. Freed, MD, MPH, Sarah J. Clark, MPH

PEDIATRICS (doi:10.1542/peds.2010-1779)






Yes To Telephone Therapy For Depression

Treating clinical depression on the telephone is nearly as effective as face-to-face consultations, a new Brigham Young University study finds.



The trial run included 30 people newly diagnosed with major depression. Instead of eight scheduled visits to the clinic, the participants covered the same material during a series of phone calls with the therapist. Calls varied in length, ranging from 21 to 52 minutes. The patients did not receive antidepressant medication.



At a six month follow-up, 42 percent of participants had recovered from depression. For comparison, similar therapy conducted in person has a 50 percent recovery rate.



"Offering a phone or webcam option for psychotherapy does appear warranted from an efficacy point of view," said Diane Spangler, a BYU psychology professor and a coauthor on the study. "It's more user- friendly - no commutes, more flexibility of place and time - and has no side effects."



Over-the-phone therapy may not be for everyone. One-third of eligible participants declined the option for telephone consultations, preferring the psychotherapist's couch to the one in their living room. But for those comfortable with phone calls, therapy could soon be cheaper, more convenient and minus awkward waiting rooms.



Though a sample of 30 people is not large, the BYU researchers cite a previous antidepressant drug trial that happened to include a telephone counseling component. In that trial, the added benefit from phone counseling matched the results attained by the new BYU study.



The study appears in the June issue of Behavior Therapy. Steve Tutty, a former grad student who worked with Spangler, is the lead author.


Multidisciplinary Expert Panel Highlights Boehringer Ingelheim??s Continuing Commitment To Research In Parkinson??s Disease

Boehringer Ingelheim announced today first results of a pan-European study1 investigating the importance and relevance of depressive symptoms in Parkinson`s disease (PD). These first study findings clearly show that depressive symptoms of PD are highly prevalent. Depressive symptoms were observed in 27 percent of the 1023 PD patients studied, of which as many as 64 percent received therapy for their depressive symptoms. Nevertheless, the study further concludes that despite being treated with a variety of antidepressants, 39 percent of the patient group continue to experience sustained depressive symptoms.


Pramipexole in Parkinson??s disease: bringing a decade of patient experience to the focus of future research was the topic of focus at today??s event sponsored by Boehringer Ingelheim, where early results of the study were announced. To mark a decade of extensive research with pramipexole in Parkinson??s disease, the session was opened by Dr Alessandro Banchi, Chairman of the Board of Directors of Boehringer Ingelheim, who emphasised the company??s commitment to research and development in the field of neurology and its role in Parkinson??s disease research.


An international expert panel presented data on novel aspects of PD research, highlighting three important areas including neurodegenerative pathways, the clinical benefits of early initiation of dopaminergic therapy and new aspects of the management of highly prevalent mood symptoms in PD patients.


Commenting on the latest understanding of the neurodegenerative pathway and the role of dopamine in Parkinson??s disease, Professor Anthony Schapira, M.D., Royal Free & University College Medical School, London, United Kingdom said: Since the discovery in the 1960s of the dopamine deficiency in the PD striatum, symptomatic treatment focused on addressing this problem with the use of the dopamine precursor levodopa. Meanwhile, dopamine agonists - which act directly on the dopamine receptors in the brain - are the most extensively studied class of drugs in PD and are widely used in the treatment of PD symptoms. Preliminary studies have suggested that these drugs may slow progression, but this needs to be confirmed by additional trials which are ongoing.2


A recently emerging area of PD research relates to the non-motor symptoms of the disease. Non-motor symptoms, such as the depressive symptoms of PD, are often a first indicator of Parkinson??s disease, occurring in many cases already in the early stages of the disease. PD is frequently complicated by psychiatric syndromes and cognitive impairment, affecting up to 90 percent of patients with idiopathic PD. These complications include depressive symptoms such as mood disorders, adjustment disorders, anxiety syndromes, psychosis or delirium and have been shown to precede development of motor symptoms, suggesting these symptoms are a neurological sign of PD.3















Recent research with pramipexole, a non-ergot dopamine agonist, has demonstrated advantages in clinical studies in managing the depressive symptoms of PD. "In addition to successfully managing the motor symptoms of PD, and significantly improving tremor in patients with treatment-resistant tremor, pramipexole has been shown to also improve motivation and reduce depressive symptoms associated with the disease, said Professor Matthias Lemke, M.D., Professor of Psychiatry and Medical Director at the Rheinische Kliniken, Bonn, Germany who presented the latest data on PD related depressive symptoms.4,5,6,7,8


Professor Werner Poewe, M.D., Universittsklinik fr Neurologie, Innsbruck, Austria outlined how new approaches to early PD treatment can help improve these symptoms as well as delaying motor complications: This research supports the opinion among experts that dopaminergic treatment in the early stages of the disease can bring additional benefit to patients who have developed Parkinson`s disease through control of motor and potentially non-motor symptoms.9 The long-term hope is that current research will bring us closer to a better understanding of Parkinson`s disease and the potential for a neuroprotective effect in this class of drugs.


About Parkinson??s Disease


Parkinson??s disease is the second most common chronic neurological disorder in older adults after Alzheimer`s. Its worldwide prevalence is estimated to be approximately one to two percent of those over 65 years.10,11 Although traditionally PD is associated with motor symptoms (such as tremor, rigidity, slowed motion, imbalance, shuffling gait, loss of facial expression), the non-motor symptoms, including depressive symptoms, pain, cognitive impairment and sleep disorders can be significant. The symptoms can vary from patient to patient, but worsen over time.


About pramipexole


Pramipexole (known in Europe under the trade names Sifrol and Mirapexin and in the U.S.A. as Mirapex) is a compound from Boehringer Ingelheim research first licensed in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa.


Pramipexole was licensed in April 2006 throughout the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) and is also approved in Australia, Brazil, Canada, Mexico, U.S.A. and others.


The most commonly reported adverse reactions in early and late Parkinson??s disease in clinical trials were dizziness, involuntary movement, postural hypotension, constipation, hallucinations, headache, difficulty falling asleep, sleepiness, nausea and fatigue.


The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, and tiredness.


Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.


About Boehringer Ingelheim


The Boehringer Ingelheim group is one of the world??s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.


In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.


References:


1 Barone P, Groot AA de, Goetz CG, Koester J, Leentjens AFG, Poewe W, Rascol O, Reichmann H, Schapira AH, Tolosa E . Depressive symptoms in Parkinson`s disease: design and methods of a prospective observational study. Movement Disorders, Vol. 21, Suppl. 15, 2006: S476. Poster 548

2. Schapira AHP, Disease modification in Parkinson??s disease, Lancet Neurol 3 (6), 362-368 (2004)

3. Chaudhuri KR, Healy DG, Schapira AHV. Non-motor symptoms of Parkinson`s disease: diagnosis and management. Lancet Neurology 2006; 5:235-245

4. Weiner et al. Relat Dis 2001; 7(2): 115-120

5. Pogarell et al. J Neurol Neurosurg Psychiatry 2002; 72(6): 713-720

6. Lemke et al. J Neuropsychiatry Clin Neurosci 2005 Spring;17(2):214-20

7. Lemke MR, Brecht HM, Koester J, Reichmann H. Effects of the dopamine agonist pramipexole on depression, anhedonia and motor functioning in Parkinson`s disease. J Neurol Sci 248 (1/2) , 266-270 (2006)

8. Barone et al. J Neurol, J Neurol 253 , 601-607 (2006)

9. Goetz CG, Poewe W, Rascol O, Sampaio C. Evidence-based medical review update: pharmacological and surgical treatments of Parkinson`s disease: 2001 to 2004. Mov Disord 20 (5), 523-539 (2005)

10. Schapira AHV et al. Design of a randomized, placebo-controlled trial of immediate vs deferred pramipexole for early-onset Parkinson??s disease. Abstract no. P511, presented at MDS 2006; Kyoto, Japan.

11. de Rijk MC, Tzourio C, Breteler MM et al. Prevalence of Parkinsonism and Parkinson??s disease in Europe: the EUROPARKINSON Collaborative Study. European Community Concerted Action on the Epidemiology of Parkinson??s disease. J Neurol Neurosurg Psychiatry 1997;62:105.


1999 - 2007 Boehringer Ingelheim GmbH, Germany. All rights reserved


Boehringer Ingelheim



View drug information on Mirapex; Pramipexole.

Lack Of Social Support Tied To Parental Depression

The latest research from Family Relations shows that parents in low-income environments are more prone to depression when there is a lack of social support.


This is especially prevalent in rural regions, where mental health and social resources can be deficient.


Social support mechanisms such as community groups, churches, and school or sports-related activities, can act as a barrier against negative thinking and allow parents who are prone to depression, in order to make better, more positive choices and engage in healthy parental practices.


The findings support a holistic care plan for families in need, combining skill-based interventions with social recommendations.


These measures may help to decrease the detrimental effects of economic stress on individual and family functioning.

European Research Council Grant For Neuroscience Research

Zachary Mainen, coordinator of the Champalimaud Foundation Neuroscience Programme at the IGC, has become one of the most recent winners of the prestigious and highly competitive European Research Council grants, to the value of 2.3 million euro, for a period of five years. This grant, which recognises Mainen's contribution to the Neuroscience field, will be used to elucidate the biological role of the neurotransmitter serotonin. The ERC is the most prominent European organism supporting scientific research. Zachary Mainen, north-american, has published over 30 studies in leading scientific journals. In 2007 he left the Cold Spring Harbour Laboratory for the Neuroscience Programme and is now living in Portugal.



Zachary Mainen and his group propose to shed light on one of the most enigmatic topics in Neuroscience - the exact role of serotonin in controlling vital behaviours such as eating, sleeping or breathing, and associated psychiatric disorders, such as anxiety, depression, migraine or eating disorders.



According to Mainen, "Anti-depressant drugs such as Prozac increase levels of serotonin in the brain, but little is known about what causes the brain to release its own serotonin or exactly how it affects the functioning of the nervous system. We are developing novel tools that will allow us to make definitive tests of serotonin function and gain insight into how this very important neurotransmitter actually functions in the brain. Ultimately, our studies may have clinical applications, as they may contribute to more effective drugs for behavioural disorders or ultimately to more advanced genetic therapies."



The tools the team of scientists is developing, based on genetics, optical imaging and electrophysiology (recording the electrical activity of nerve cells), are a valuable resource for the entire scientific community, across the world.



The Advanced Investigator Grant which Zachary Mainen has just received is awarded to senior researchers, and is aimed at encouraging and supporting innovative and ground-breaking projects, on the basis of scientific excellence alone, in any field of research. In this second edition of these grants, a total of 512 applications were received, from across Europe. This grant is the first awarded to a senior life scientist working in Portugal.


Study Of Brain Blood Flow May Lead To Improved Depression Treatment

The usefulness of established molecular imaging/nuclear medicine approaches in identifying the 'hows' and 'whys' of brain dysfunction and its potential in providing immediately useful information in treating depression are emphasized in a study in the August Journal of Nuclear Medicine.



"Individuals in a depressed emotional state have impaired cerebral (brain) blood flow," explained Omer Bonne, head of inpatient psychiatry and associate professor in the Department of Psychiatry at Hadassah-Hebrew University Medical Center in Jerusalem, Israel. "Clinical improvement in depression is accompanied by diverse changes in cerebral blood flow, according to whether patients are treated with medication or electroconvulsive treatment," he noted. "We found that antidepressant medicines normalized decreased brain blood flow usually seen in patients with depression, while electroconvulsive treatment was associated with additional decreases in blood flow," he reported. "Currently, clinical psychiatry is based almost solely on subjective observer-based judgment. Our findings suggest that objective imaging evaluations could support subjective clinical decisions," he said.



Using SPECT (single photon emission computed tomography) -- a molecular imaging/nuclear medicine procedure in which injected radiotracers are utilized to produce three-dimensional, computer-reconstructed images that reveal information about both structure and function -- investigators confirmed already published findings that cerebral blood flow in depressed patients is lower than in healthy control subjects, especially in frontal, limbic and subcortical brain regions. "We wanted to see whether improvement in clinical depression is accompanied by changes -- increases -- in cerebral blood flow," he said. "We found that cerebral blood flow increased only in patients whose depression improved. In contrast, cerebral blood flow remained unchanged in patients whose depressed condition persisted," detailed Bonne.



Depression is a serious and debilitating -- yet treatable -- disease that affects every aspect of a person's health. Estimates indicate that 19 million Americans are affected by depression each year, along with their family members, friends and co-workers. Depression may be related to a chemical imbalance in the brain that makes it hard for the cells to communicate with one another. A variety of antidepressant medications and psychotherapies are used to treat depression. Sometimes electroconvulsive therapy -- applying an electric current briefly to produce a seizure -- is useful, especially for those whose depression is severe or life threatening or for whom repeated treatment trials with antidepressant drugs failed.



"Interestingly, patients' response to two different classes of antidepressant medicines that target different neurotransmitters is associated with a similar improvement in cerebral blood flow," he noted. "However, cerebral blood flow continued to deteriorate in patients who responded to electroconvulsive therapy," added Bonne, who helped implement functional brain imaging research in psychiatry at Hadassah. Israeli researchers studied 33 depressed patients and 25 healthy control subjects with SPECT and the radiotracer 99mTc-HMPAO.
















"Our findings may aid in elucidating the mechanism of depression and its treatment," said Bonne. "There may be more than one mechanism responsible for the development of depression and for mediating response to its treatment," he added. Additional research could examine whether it's possible to use functional imaging techniques to determine which patients would benefit from drug treatment and which would respond better to electroconvulsive therapy, explained Bonne. Future research should also examine the differences in brain blood flow in patients at later time points, he said.







"99mTc-HMPAO SPECT Study of Cerebral Perfusion After Treatment With Medication and Electroconvulsive Therapy in Major Depression" appears in the August issue of the Journal of Nuclear Medicine, which is published by SNM, the world's largest molecular imaging and nuclear medicine society. Co-authors include Yoav Kohn and Bernard Lerer, Department of Psychiatry, and Nanette Freedman, Hava Lester, Yodphat Krausz and Roland Chisin, Department of Medical Biophysics and Nuclear Medicine, at Hadassah-Hebrew University Medical Center in Jerusalem, Israel.




About SNM -- Advancing Molecular Imaging and Therapy



SNM is an international scientific and professional organization of more than 16,000 members dedicated to promoting the science, technology and practical applications of molecular and nuclear imaging to diagnose, manage and treat diseases in women, men and children. Founded more than 50 years ago, SNM continues to provide essential resources for health care practitioners and patients; publish the most prominent peer-reviewed journal in the field (the Journal of Nuclear Medicine); host the premier annual meeting for medical imaging; sponsor research grants, fellowships and awards; and train physicians, technologists, scientists, physicists, chemists and radiopharmacists in state-of-the-art imaging procedures and advances. SNM members have introduced -- and continue to explore -- biological and technological innovations in medicine that noninvasively investigate the molecular basis of diseases, benefiting countless generations of patients. SNM is based in Reston, Va.; additional information can be found online at snm/.


New Drive To Improve Employers' Attitude To The Mentally Ill Launched In UK

A new initiative encouraging employers to improve the way they deal with mental health in the workplace has been launched by Health Minister Rosie Winterton to mark World Mental Health Day.



The three year initiative, called 'Action on Stigma', urges employers to sign up to a set of anti-stigma principles - for example, demonstrating that they have made changes in their work environment and employment practices to ensure that people with mental health problems are treated fairly and equally with others.



To mark World Mental Health Day, the Department of Health today published a document setting out these principles, highlighting existing best practice and the vision for the 'Action on Stigma' initiative. It also announced the start of a listening exercise to find out the views of employers and what support they will need to meet these principles.



Many employers who have taken part in projects to make their workplace culture more 'mental health friendly' have reported reduced staff turnover and sickness absences. Despite this:



Only about 20% of people with severe mental health problems are employed, compared to 65% of people with physical health problems and 75% for the whole adult population



Even for people with more common types of mental illness, such as depression, only about half are competitively employed



However, people with mental health problems have the highest 'want to work rate' with up to 90% wanting to work, compared to 52% for disabled people generally.



Although some of the principles are voluntary, adopting them will help public sector organisations, including local councils, government departments and hospitals, to meet the requirements of a new duty under the Disability Discrimination Act which comes into force in December 2006. This will require them to set out precisely how they intend to eliminate unlawful discrimination and promote equality of opportunity.



Speaking at a visit to a programme run by Oxleas Mental Health Trust in South East London to encourage businesses to employ people with mental health problems, Rosie Winterton said: "There is no better time than World Mental Health day to remind people that one in four of us will suffer from a mental health problem at some point in our lives and the cost to business and society is substantial. Ignorance and stigma still surrounds the issue of mental ill-health and when someone does develop a problem, they often do not get the support they need from society to help them recover. We all have a role to play in helping to tackle this issue. Employers can help by raising awareness of mental health issues amongst staff, supporting those affected and combating discrimination against staff and customers. This is good for staff and good for employers, who we know will benefit from reduced staff turnover and sickness absences. I am delighted to launch this new initiative and I urge employers to take the problem of mental health in the workplace seriously. We want employers to own this initiative and so we intend to spend the next few months listening to businesses about the support they need and discussing the set of principles we are proposing. Our priority must be to get our own house in order, so the first target of this drive will be the NHS and other public service organisations."
















Service user Emma Lindley, 27, of Manchester, said she was "ostracised" after she being off sick from an adminstrative job at a college of higher education for two months while being treated for bipolar disorder.



She added: "Some colleagues avoided me and dropped their eyes rather than have to greet me. Others began to patronise me even though they had always given me professional respect previously. People talked about me as though I wasn't there or fell out with me for no reason. I began applying for jobs very soon after returning because of the way I was treated. I left the post a few months later."



Department of Work and Pensions Minister, Lord Hunt, said: "Work is important and beneficial to our physical and mental well-being. Because of this, it is essential that we remove the barriers that prevent people starting, returning to, or remaining in work. I welcome this initiative, which will make an important contribution to the Government's strategy to improve health and well-being of the working age population."



Bill Callaghan, Chair of the Health and Safety Commission said: "I fully support the 'Action on Stigma' campaign. It's important that our organisations raise awareness of mental health issues amongst our staff and we support those affected. Being 'mental health friendly' is good for our businesses, helps our employees and customers and improves the health and wellbeing of all."



Hugh Taylor, Acting Permanent Secretary for the Department of Health, said: "Mental ill-health has an impact on both individuals and the organisations that employ them. We have a key role to play, by creating a work culture where staff are more aware of causes of mental illness, are not scared to ask for help and where discrimination is deemed unacceptable. I welcome this initiative and look forward to seeing how the Department of Health can, as an employer, play its part."



David Nicholson CBE, NHS Chief Executive, said:"People with mental health problems are often excluded from jobs, public services and playing a full part in our communities. The NHS is already doing a lot to increase social inclusion, promote mental wellbeing and support patients into employment. I welcome this initiative which will build on this good work and urge NHS organisations to get involved in changing the way we deal with mental health in the workplace."







The document is available on shift.uk/employment



In Scotland, the national anti-stigma campaign, 'see me', was launched in October 2002. It is run by five mental health organisations and is funded by the Scottish Executive. For further information, contact Katrina Beaton or Rebecca Charles at IAS Smarts on 0131 555 0425



For further information please go to:
UK Department of Health

UT Center Of Excellence On Mood Disorders Combines Discovery, Patient Care

Innovative neuroscience research and expanded clinical care have been launched at the new Center of Excellence on Mood Disorders at The University of Texas Medical School at Houston.


"New research here is trying to pinpoint the neurobiological mechanisms involved in mood disorders," said Jair Soares, M.D., co-director of the center and chairman of the Department of Psychiatry and Behavioral Sciences at The University of Texas Medical School at Houston. "We need to link those discoveries to a better way to treat the disease. In the new center, we'll be able to combine high-level care with research."


According to the National Institute of Mental Health (NIMH), 9.5 percent of the United States population age 18 years and older has a mood disorder in a given year. Mood disorders include bipolar disorder and depression.


"All of us, if we don't have a family member with a mood disorder, we have a friend or co-worker who suffers from one," said Soares, who is executive director of the UT Harris County Psychiatric Center and chief of psychiatry at LBJ General Hospital and Memorial Hermann-Texas Medical Center. "New research is showing that a mood disorder has nothing to do with will. These conditions are brain diseases."


The new center will be able to link with other strong resources of The University of Texas Health Science Center at Houston, including the Center for Neurobehavioral Research on Addictions and the Department of Diagnostic and Interventional Imaging, both at the medical school, as well as The University of Texas School of Public Health, which is based in Houston.


"Mood disorders ruin lives; break up families; shorten lives through suicide and medical illnesses. Every phase of life is affected by mood disorders," said Alan Swann, M.D., professor and co-director of the UT Center on Mood Disorders. "There's a tremendous need for this center. We will evaluate people, treat and conduct research in a single place. We will be able to educate our students and residents, our patients and their families, and the general public."


Giovana Zunta-Soares, M.D., assistant professor of psychiatry and behavioral science at the medical school, said researchers including those at the UT Medical School at Houston are beginning to learn more about the relationship between changes in the brain and mood disorders.


"We know bipolar patients have subtle abnormalities in key brain regions involved in modulation of emotions, but we don't know why," Zunta-Soares said. "We would like to eventually have a way to diagnose the disease physiologically just as we do in other diseases such as high blood pressure, for example."


Brain imaging, cognitive neuropsychology, neurophysiology and genetics are components of new research at the Center:















-- Adult patients with bipolar disorder are being recruited for an imaging study that will look for changes in the brain that may indicate how mood-stabilizing medications help them.


-- For an imaging study looking at the anatomy and biology of important areas of the developing brain, researchers are seeking children ages 7 to 17 who have been diagnosed with bipolar disorder as well as healthy children of the same age. The children with bipolar disease will be treated with mood-stabilizing medications.


-- A double-blind, placebo-controlled medication trial is studying uridine, a naturally occurring chemical made by the liver that is involved in many of the body's processes, including the use of energy by cells. Researchers are testing uridine for safety and to assess whether it is beneficial for the depressive symptoms of bipolar disease in adults.


-- Researchers will analyze blood levels from the new Serum Markers of Ilness Pathophysiology in Mood Disorders, a repository of samples, in search of biochemical and genetic abnormalities to help understand biological conditions associated with bipolar disorder.


-- Anatomical and biochemical measurements of certain brain regions will be taken in an imaging study looking at the differences along the bipolar spectrum, which includes bipolar disorder type I, bipolar disorder type II, cyclothymia and bipolar disorder not otherwise specified.


-- Two studies will look at families. The first is enrolling parents diagnosed with bipolar disease and their children age 7 to 17 regardless of whether the children have the disease. The second is recruiting a family member with bipolar disease and a non-affected, first-degree relative (sibling, parent or child).


-- Researchers will investigate neurophysiological and neurochemical studies of bipolar disorder and its relationships to impulsivity, personality disorders and substance-use disorders.
In addition to mood disorders, the faculty practice at UT Physicians' clinics of the Department of Psychiatry and Behavioral Sciences treats patients with anxiety disorders, childhood disorders, personality disorders, schizoaffective disorder, schizophrenia and substance-related disorders.


In addition to mood disorders, the faculty practice at UT Physicians' clinics of the Department of Psychiatry and Behavioral Sciences treats patients with anxiety disorders, childhood disorders, personality disorders, schizoaffective disorder, schizophrenia and substance-related disorders.

Innovative Federal Partnership To Study Combat Related Substance Use And Abuse

Eleven research institutions in 11 states will receive more than $6 million in federal funding from fiscal year 2010 to support research on substance abuse and associated problems among U.S. military personnel, veterans, and their families. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, is collaborating with the Department of Veterans Affairs, to award grants that will examine substance abuse related to deployment and combat related trauma. The National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Cancer Institute (NCI) are also NIH partners in this endeavor. NIH is awarding more than $4 million in grant funding; the VA, around $2 million.



The funding opportunity announcement, released last July, solicited applications on the causes, screening, identification, prevention, and treatment of substance use and abuse - including alcohol, tobacco, illicit and prescription drugs and associated problems. Institutions that are receiving awards are Brandeis University, Waltham, Mass.; Dartmouth College, Hanover, N. H.; the Medical University of South Carolina, Charleston; the National Development and Research Institutes, New York City; the University of California, San Francisco; the University of Minnesota, Twin Cities, Minneapolis and St. Paul; The University of Missouri, Columbia; and VA Medical Centers in West Haven, Philadelphia, Little Rock and Seattle.



Most of the research is directed at substance abuse and related conditions experienced by veterans returning from wars in Iraq and Afghanistan. There is a growing awareness that military personnel returning from these prolonged conflicts have a variety of serious problems, including depression, anxiety, sleep disturbances, and substance abuse. Some face these and other diverse symptoms as a result of traumatic brain injury or post traumatic stress disorder related to battle experiences. Many of these conditions are interconnected, and contribute to individual health and family relationship crises. There has been little research on how to prevent and treat unique characteristics of these wartime-related issues.



Several projects will look at treatment seeking patterns - why and when veterans ask for help, and why many don't. Scientists will explore treatment strategies, including cognitive behavioral therapy and Web-based approaches as well as the most effective therapies for soldiers who have co-occurring disorders, such as depression and substance abuse. Researchers will also determine if early intervention, within two months of returning from war, can improve outcomes. The research will examine the high rate of smoking among returning military personnel. "Smoking prevalence in the military, especially among men aged 18 to 25 years, is nearly double that of the civilian population," said Cathy Backinger, Ph.D., chief of NCI's Tobacco Control Research Branch. "NCI research funded under this initiative, looking at reducing smoking by military personnel, will go a long way toward helping service members avoid developing lung cancer and the many other diseases caused by smoking." In addition, some of the newly funded research projects will examine how veterans attempt to reintegrate into their work and family lives after experiencing war conditions.
















"These research projects will give us important information about the ways that combat stress and substance abuse affect returning military personnel and their families," said NIDA Director Dr. Nora D. Volkow. "This knowledge will be used to improve our prevention and treatment approaches, which we hope will reduce the burden of combat-related trauma. Working cooperatively with the VA and other partners will help in finding solutions for this shared concern."



"The Department of Veterans Affairs has a commitment to meet the full range of our Veterans' physical and mental health care needs, and that includes addressing substance abuse," said Dr. Joel Kupersmith, chief research and development officer for VA. "This coordinated research effort is one more way we are turning that commitment into action."



"NIAAA-supported research has documented a significant association between combat deployment of U.S. military personnel to Iraq and Afghanistan and the onset of alcohol problems upon their return to the U.S.," notes NIAAA Acting Director Kenneth R. Warren, Ph.D. "We hope that by developing new strategies to prevent and treat alcohol abuse among returning servicemen and women, these new research projects will improve the lives of military families."


Preclinical Data At Neuroscience 2010 Show Naurex's Novel Antidepressant GLYX-13 Shares Key Efficacy Mechanisms With Ketamine

Naurex Inc., a company developing innovative treatments to address unmet needs in psychiatry and neurology, reported that data presented at Neuroscience 2010 show that GLYX-13, its clinical-stage candidate for the treatment of depression, shares key mechanistic features associated with the antidepressant efficacy of the NMDA receptor antagonist ketamine.* Numerous studies have shown that ketamine has a markedly faster onset of action than other antidepressants (within hours, instead of weeks) and alleviates depression symptoms in a greater proportion of patients, but its clinical utility has been limited by the high incidence of addictive, dissociative and sedative side effects seen at dose levels close to the therapeutic dose.


GLYX-13 is Naurex's lead glycine-site functional partial agonist (GFPA) selective modulator of the NMDA receptor (NMDAR). The novel GFPA class of compounds has been specifically designed by Naurex to achieve the well-documented efficacy of classic NMDAR-modulating drugs such as ketamine, while avoiding the serious side effects that have limited their clinical utility.


In previous studies in preclinical models of depression, GLYX-13 demonstrated antidepressant-like effects consistent with those of ketamine. In the preclinical studies presented at Neuroscience 2010, researchers found that three key features associated with the molecular mechanism underlying ketamine's antidepressant efficacy are also seen with GLYX-13. Similar to ketamine, GLYX-13 appears to exert its antidepressant-like effects, at least in part, through AMPA receptor-dependent activity, shown by an increase in AMPA throughput and blocking of antidepressant effects when an AMPA antagonist is administered. In these studies, antidepressant-like efficacy was demonstrated within minutes of administering a single dose of GLYX-13, and it lasted more than two weeks post-dosing. No ketamine-like side effects were observed.


"Our GFPA modulators are designed to achieve ketamine-like efficacy without ketamine's side effects," said Joseph Moskal, Ph.D., founder, president and chief scientist of Naurex. "These new preclinical data confirm that the efficacy mechanism of GLYX-13 is similar to that of ketamine. Since ketamine's preclinical efficacy has been shown to be predictive of its antidepressant efficacy in humans, these data give us additional confidence that the strong antidepressant efficacy observed in preclinical studies of GLYX-13 will also be predictive of the antidepressant efficacy we will be evaluating in our upcoming Phase II trial in treatment-resistant patients."


The clean safety profile of GLYX-13 has been confirmed in a Phase I clinical trial in healthy volunteers. No psychotomimetic or cardiac side effects were observed at therapeutic doses. In preclinical studies, GLYX-13 has demonstrated the widest therapeutic ratio between efficacy and side effects (greater than or equal to 500:1) of any known NMDAR modulator.















"As envisioned by our founding scientists who discovered the GFPA modulators, it appears that the GFPA mechanism of GLYX-13 results in 'just right' modulation of the NMDA receptor, achieving efficacy consistent with that of NMDAR blockers such as ketamine, but without the prohibitive side effects that plague those agents," said Derek Small, acting CEO of Naurex. "We are eager to assess GLYX-13 in our upcoming Phase II trial in treatment-resistant depression, testing whether it can help some of the millions of patients who are poorly served by existing therapies, and provide relief within hours rather than weeks of receiving a single dose."


Naurex will initiate a Phase II proof-of-concept trial early next year to evaluate GLYX-13 in patients who are not achieving an adequate response to their current antidepressant agents.


In addition to GLYX-13, Naurex is developing the NRX-1050 series of GFPAs, including numerous second-generation, orally available molecules with structures and mechanisms of action similar to GLYX-13.


Neuroscience 2010: the 40th annual meeting of the Society for Neuroscience, is being held Nov. 13-17 in San Diego, CA. It provides the world's largest forum for neuroscientists to debut research and network with colleagues from around the world.


The Antidepressant and Anxiolytic Properties of GLYX-13: A Novel NMDA Receptor Gylcine Site Functional Partial Agonist, J. S. Burgdorf (1), L. Westrich (2), J. Sprouse (2), R. A. Kroes (1), R. M. Burch (3) & J. R. Moskal (1)


(1) Falk Center for Molecular Therapeutics, Department of Biomedical Engineering, McCormick School of Engineering, Northwestern University, Evanston, IL; (2) Lundbeck Research USA, Paramus, NJ; (3) Naurex Inc., Evanston, IL


About NMDA Receptor Modulators and Depression


The glutamate receptor subtype known as NMDA plays a central role in modulating aspects of brain activity. The antidepressant effects of known NMDAR modulators, such as ketamine, have been confirmed in multiple clinical studies over the last decade. These studies have shown dramatic efficacy in patients with treatment-resistant and bipolar depression, demonstrating response rates greater than 50%, fast onset of action within hours of a single dose and a long duration of effect. The antidepressant efficacy of ketamine has been underscored in recent studies published in Science and the Archives of General Psychiatry. But ketamine and other known NMDAR blockers are also associated with significant toxicities at or near their therapeutic doses. These side effects, which include schizophrenia-like effects, sedation and abuse and addiction potential, have limited the therapeutic potential of these agents.


About Glycine-Site Functional Partial Agonists


GFPAs modulate the NMDA receptor in a novel and selective way that results in the largest therapeutic index of any known NMDAR modulator. GFPAs are being developed with the goal of achieving the antidepressant efficacy and rapid onset seen with conventional NMDAR modulators, but without their limiting side effects. The efficacy potential of GFPAs has been demonstrated in animal models in a number of CNS disorders, including major depressive disorder, neuropathic pain, schizophrenia, anxiety, Alzheimer's disease and other cognition disorders. In these studies, GFPAs did not exhibit the schizophrenia-like side effects associated with conventional NMDAR-modulating drugs.