Sunday, May 31, 2009

Antidepressants Cut Effectiveness of Tamoxifen in Breast Cancer

Tamoxifen, a breast cancer medicine used by millions of women, doesn’t work when taken with antidepressants like Eli Lilly & Co.’s Prozac, Pfizer Inc.’s Zoloft and GlaxoSmithKline Plc’s Paxil, a study says.

Tumors were more than twice as likely to return after two years in women taking the antidepressants while on the cancer drug, compared with those taking tamoxifen alone, the study showed. The research, by Medco Health Solutions Inc., was presented today at a meeting of the American Society of Clinical Oncology in Orlando.

Doctors began treating hot flashes with antidepressants, an unapproved use, after a U.S. study seven years ago linked the former standard remedy, hormone replacement therapy, to an increased risk of breast cancer and heart attacks. Other types of antidepressants, such as Wyeth’s Effexor, may be safer for women on tamoxifen than Paxil or Prozac, said Powel Brown, director of cancer prevention at the Lester and Sue Smith Breast Cancer Center at Baylor College of Medicine in Houston.

“Effexor doesn’t interfere with tamoxifen so that is the preferred drug for oncologists to treat hot flashes,” said Brown, who wasn’t involved in the study. “We need to get that message out to primary care doctors and psychiatrists and gynecologists so they will be aware that antidepressants like Paxil have a risk of inhibiting tamoxifen.”

READ MORE @ BLOOMBERG

Saturday, May 30, 2009

New tool to improve patient understanding of long-acting injectable antipsychotic therapies (LAT) unveiled in April issue of Psychiatry 2009

'GAIN' offers structured approach for physicians to discuss potential reasons for use of LAT

Titusville, NJ, May 27, 2009 – A new instrument for improving patient understanding and acceptance of long-actingectable antipsychotic therapy (LAT inj) has been published in the April edition of Psychiatry 2009.1 This novel, psychosocial approach encompasses Goal setting, Action planning, Initiating treatment, and Nurturing motivation (GAIN) through the use of a clinical discussion tool.

Nonadherence to oral antipsychotic medications is one of the most significant clinical challenges in psychiatry and behavioral medicine, with rates of nonadherence estimated to be as high as 50 and 75 percent in the first and second years of treatment.2,3 Despite evidence suggesting that continuous antipsychotic treatment is more effective than interrupted treatment, and the fact that LAT is strongly recommended in many cases4, the prescription of LAT remains low in the United States. GAIN was developed to assist physicians and other clinicians by providing them with an effective approach to engage patients in a discussion of the consideration of LAT and in overcoming any related barriers.

"Long acting injectable therapies have typically been reserved for the most difficult patients where nonadherence to medication has been identified as a primary obstacle, usually because of repeated relapses. Utilizing long-acting therapies administered by a healthcare professional more widely has an advantage over daily oral formulations in that healthcare professionals will know when their patients are not taking their medications before the consequences of nonadherence occur. Early intervention may well prevent relapse," said Nina R. Schooler, Ph.D. Professor of Psychiatry & Behavioral Sciences at State University of New York Downstate Medical Center. "However, it is often difficult for clinicians to discuss injectable medications with patients because of reluctance to take injections and stigma. With GAIN, we now have an effective tool to use in approaching a recommendation and have the possibility to help more patients with schizophrenia as we work together to control their symptoms."

READ MORE @ EUREKALAERT

Friday, May 29, 2009

Dementia care 'human rights' call

Urgent action should be taken to protect the human rights of people with dementia in care homes, a charity says.

The call from Alzheimer Scotland came as two watchdogs published a report after visiting 30 care homes and interviewing 1,335 residents.

It said drugs had been hidden in food to make patients more manageable and about half never went outside.

The Scottish Government is to launch a national dementia strategy later on Thursday.

About 65,000 people in Scotland have dementia and about 40% are in care homes or hospitals.

The Care Commission and Mental Welfare Commission visited a sample of homes between August and March and detailed their findings in a report, Remember I'm Still Me.

It said before the patients were admitted most had already had a good medical assessment, with input from GPs and dieticians.

But after admission, the report said very few had annual GP health checks and there was little evidence that medication was regularly reviewed.

READ MORE @ BBC NEWS

Thursday, May 28, 2009

Paliperidone May Lower Recurrence Risk in Schizophrenia: Presented at APA

Post hoc analyses of a trial of the long-acting antipsychotic drug paliperidone, given by injection, appears to decrease the likelihood of recurrence in schizophrenic patients, according to researchers here at the 162nd Annual Meeting of the American Psychiatric Association (APA).

Larry Alphs, MD, PhD, Ortho-McNeil Janssen Scientific Affairs, Titusville, New Jersey, noted on May 20 that evidence exists to support limiting recurrences in schizophrenia, because brain mass is seen to decrease over time in patients with the disorder.

"The brain deteriorates with each progressive relapse," said Dr. Alphs.

Of the 681 patients tested in the double-blind, open-label trial, 408 were included in the recurrence-prevention phase.

Patients were given a month-long treatment with paliperidone palmitate injection or placebo. Recurrence rates were lower for patients diagnosed <=5 years before the study compared with placebo (20% vs 44%, P = .0025). For those who were diagnosed >5 years before the study, the difference in recurrence was similarly significantly lower with the drug (13% vs 48%, P < .0001).

Paliperidone use was also associated with a longer time to recurrence than placebo for both diagnosis time cohorts (P = .0011 and P < .0001, respectively).

Although what a comparator active antipsychotic drug would have shown in such a study is unknown, Dr. Alphs said that "most [antipsychotic drugs] would do similar things."

READ MORE @ DOCTOR'S GUIDE

Wednesday, May 27, 2009

Combo Treatment Relieves Comorbid Pain and Depression

A two-pronged intervention of optimized antidepressant and behavioral pain management therapy improves symptoms of comorbid pain and depression, a randomized trial showed.

The intervention yielded a clinically and statistically significant reduction of at least 50% in depression symptoms and at least 30% in pain for three times more patients than did usual care, which was significant at both six months (23.6% versus 7.9%) and 12 months (26.0% versus 7.9%).

The number needed to treat to improve pain to this threshold was 4.1, and it was 4.8 to achieve a response for depression, Kurt Kroenke, M.D., of Indiana University in Indianapolis, and colleagues reported in the May 27 issue of the Journal of the American Medical Association.

This was similar to the number needed to treat of 4 in a Cochrane review of antidepressants compared with placebo or no treatment in medically ill adults, they noted.

READ MORE @ MEDPAGE TODAY

Tuesday, May 26, 2009

First Death for Washington Assisted-Suicide Law

A woman with pancreatic cancer has become the first person to die under a law passed last year allowing doctor-assisted suicide in Washington, according to an advocacy group that pushed for the law.

The woman, Linda Fleming, 66, of Sequim, Wash., died Thursday evening after taking lethal medication prescribed by a doctor under the law, according to a news release by the group, Compassion and Choices of Washington. The release said Ms. Fleming received a diagnosis of Stage 4 pancreatic cancer a month ago, and “she was told she was actively dying.”

Ms. Fleming was quoted in the release as saying: “I am a very spiritual person, and it was very important to me to be conscious, clear-minded and alert at the time of my death. The powerful pain medications were making it difficult to maintain the state of mind I wanted to have at my death.”

In November, voters approved the Death with Dignity Act, 58 percent to 42 percent, making Washington the second state — after Oregon — to allow assisted suicide. The laws in both states have been deeply controversial, particularly among religious groups. Washington passed its law after the United States Supreme Court in 2006 rejected an effort by the Justice Department to block Oregon’s law, which took effect in 1998.

READ MORE @ NY TIMES

Monday, May 25, 2009

The Depression Test By screening all teens, doctors hop to identify those with mental disorders

Soon after her sister committed suicide, Caroline Downing started doing poorly at school. During math tests she would freeze up, and she found her mind wandering constantly. Officials at St. Andrew's Episcopal School in Potomac gently suggested that the high school sophomore get a mental health screening.

The idea of a psychiatric evaluation sent chills down the spine of Caroline's mother, Mathy Milling Downing, who believed that her younger daughter, Candace, had committed suicide because of an adverse reaction linked to a psychiatric drug -- the antidepressant Zoloft. Shortly after Candace's death, the Food and Drug Administration placed black-box warnings on several antidepressants to say they elevated suicidal thinking among some children. If Caroline were going to get the same kind of mental health care as Candace, Downing wanted no part of it.

Downing's family offers a powerful case study into the pros and cons of new guidelines recommending widespread screening of adolescents for mental disorders: Last month, the U.S. Preventive Services Task Force, a federal group that makes public health recommendations, said that all adolescents between ages 12 and 18 should be screened for major depression. In March, the Institute of Medicine, which advises Congress on scientific matters, told policymakers that early screening was key to reducing the financial and medical burden of mental disorders in the United States.

READ MIRE @ WASHINGTON POST

Sunday, May 24, 2009

APA: Novel Antipsychotic Promising for Schizophrenia

The experimental psychotropic agent lurasidone appeared effective in acute schizophrenia, according to the first phase III data on the drug.

The intermediate 80-mg dose of the novel compound significantly improved total scores on the Positive and Negative Syndrome Scale (PANSS) by about eight points more than placebo over six weeks of treatment in the randomized controlled trial.

However, the 40- and 120-mg per day doses did not appear better than placebo for either the primary or secondary endpoints in the trial, Antony Loebel, Ph.D., of Dainippon Sumitomo Pharma America in Fort Lee, N.J., and colleagues found.

All doses appeared to be well tolerated with little impact on weight and lipids, they reported here at the American Psychiatric Association meeting.

Lurasidone is part of the pipeline of psychotropics that have been called the "me-too" medications. It has high affinity for dopamine (D2) and serotonin 5-HT2A receptors.

But Dr. Loebel highlighted its uniqueness among psychotropics in affinity for serotonin receptors implicated in the enhancement of cognition, mood, and negative symptoms (5-HT7, 5-HT1A and alpha-2c).

READ MORE @ MEDPAGE TODAY

Saturday, May 23, 2009

Results of phase III study on Labopharm's novel antidepressant published in Psychiatry (Edgemont) Journal

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the publication of Extended Release Trazodone in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Study in the May 2009 issue of the journal Psychiatry (Edgemont) (Volume 6, Number 5) (www.psychiatrymmc.com). The results of this Phase III clinical trial (study 04ACL3-001), which were originally reported by the Company in February 2008, demonstrate clear benefits for Labopharm's novel antidepressant.

More than 120 million people around the world suffer from depression. Treatment is often challenging because response to antidepressant drug therapy can vary significantly. Clinically depressed patients are typically treated with two different types of drug therapy: selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)). However, some 40 to 50% of patients being treated for depression stop taking these antidepressant drugs within the first 12 months of treatment. Frequently cited reasons for discontinuing therapy include suboptimal efficacy on depression symptoms, exacerbation of sleep disturbance, increased agitation, slow onset of action, sexual dysfunction and weight gain.

Labopharm's novel formulation of the antidepressant trazodone is designed to optimize the efficacy of trazodone, and address the major challenges in treating depression.

Summary of Results of Labopharm's Phase III Clinical Trial on Trazodone

READ MORE @ PR NEWSWEIRE

Friday, May 22, 2009

APA: Heart Risks May Impair Depression Treatment

Cardiovascular risk factors may be linked to lack of response to antidepressant treatment, researchers found.

Patients with diabetes, dyslipidemia, hypertension, and obesity were twice as likely to be unresponsive to antidepressant medication as other patients (P<0.05 to 0.01), Dale D'Mello, M.D., and Alric Hawkins, M.D., both of Michigan State University in East Lansing, reported at the American Psychiatric Association meeting.

The lack of response was not significantly more common among smokers, though.

The researchers' preliminary cohort study also revealed that those with comorbid cardiovascular risk factors were older at onset of depression and had tried -- unsuccessfully -- a greater number of antidepressant drugs.

READ MORE @ MEDPAGE TODAY

Thursday, May 21, 2009

Choice of Antipsychotics Influence Metabolic Abnormalities in Patients With Schizophrenia:Presented at APA

A prospective trial comparing 3 antipsychotic drugs revealed that clozapine is most likely to produce metabolic changes that point the way to metabolic syndrome.

However, clozapine was also most likely to control violent behaviour and metabolic consequences were most apparent for African American, researchers stated here at the 162nd Annual Meeting of the American Psychiatric Association (APA).

Menahem Krakowski, MD, New York University, New York, and Nathan Kline Institute, Orangeburg, New York, presented the findings of a randomised, double-blind study on May 20.

The study included 110 inpatients with schizophrenia or schizoaffective disorder who were randomised to receive clozapine (n = 34), olanzapine (n = 31), or haloperidol (n = 28).

At study entry, 93 patients gave blood samples for measuring fasting glucose, cholesterol and triglycerides and had at least 1 more sample collected during the 12 weeks of the study. The patients had a history of physical assaults.

READ MORE @ DOCTOR'S GUIDE

Wednesday, May 20, 2009

Fred A. Baughman Jr., MD Announces: Vets' Sudden Cardiac Deaths Are Not Suicides or Overdoses

Fred A. Baughman Jr., MD today announced the results of his research into the "series" of veterans' deaths acknowledged by the Surgeon General of the Army.

Upon reading the May 24, 2008, Charleston (WV) Gazette article "Vets taking Post Traumatic Stress Disorder drugs die in sleep," Baughman began to investigate why these reported deaths were "different." And, why they were likely, the "tip of an iceberg."

Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson were four West Virginia veterans who died in their sleep in early 2008. Baughman's research suggests that they did not commit suicide and did not overdose as suggested by the military. All were diagnosed with PTSD. All seemed "normal" when they went to bed. And, all were on Klonopin (a benzodiazepine), Paxil (an SSRI antidepressant) and Seroquel (an antipsychotic).

On January 15, 2009, the New England Journal of Medicine (Ray et al), reported that antipsychotics double the risk of sudden cardiac death.

On February 7, 2008, Surgeon General Eric B. Schoomaker, said there has been "a series of deaths in Warrior Training Units" -- "often as a consequence of the use of multiple prescription and nonprescription medicines and alcohol ... we all saw the unfortunate death of Heath Ledger, the 'Brokeback Mountain' star, who died from an accidental overdose."

READ MORE @ PR NEWSWIRE

Tuesday, May 19, 2009

Patients who survived acute MI used more aspirin, beta blockers than sudden death population examined.

Common psychotropic medications such as antipsychotics, antidepressants and benzodiazepines may contribute to an increased risk for sudden death during an acute coronary event, according to a study presented at Heart Rhythm 2009.

Jussi Honkola, MD,of the University of Oulu, Finland, and colleagues conducted a prospective substudy of the FinGesture study, comparing the medications of 321 patients who had sudden cardiac death due to an acute coronary event as confirmed by a medicolegal autopsy, with 609 patients who survived an acute MI. Researchers examined medication histories from autopsy records and conducted interviews with the patient’s relatives.

The researchers found that patients who had died had used more antipsychotics compared with the MI survivors (10.9% vs. 1.4%), more antidepressants (7.4% vs. 3%) and benzodiazepines (18.4% vs. 5%).

The study results also showed the MI survivors used beta blockers more frequently compared with those who died (adjusted OR 0.47, 95% CI 0.24-0.93, P=0.03), and aspirin use was also more common among MI survivors (adjusted OR 0.31, 95% CI 0.15-0.64, P=0.002).

Honkola J. PO02-120. Presented at: Heart Rhythm 2009; May 13-16, 2009; Boston.

FROM CARDIOLOGY TODAY, Section: ARRHYTHMIA DISORDERS, May 18, 2009

Monday, May 18, 2009

Bipolar patients often relapse: study

Results of a study suggest that bipolar disorder has a high relapse rate. In the study, researchers found evidence that three fourths of the hospitalizations for treatment of bipolar disorder are repeat admissions.

The study findings were reported today at the American Psychiatric Association's annual meeting in San Francisco.

Bipolar disorder, also known as manic depression, typically causes wide swings in mood -- sometimes from extreme incapacitating depression to euphoric recklessness.

"It is well known that bipolar disorder is a recurrent disease, so we considered it important to assess hospitalization patterns as an indication of the course of illness," principal investigator Dr. Urban sby from Danderyd University Hospital, Sweden, told Reuters Health prior to his presentation.

READ MORE @ REUTERS

Sunday, May 17, 2009

Preventing Another Camp Liberty

Midway through her 2004 deployment to Iraq's Anbar province, Navy psychologist Heidi Kraft was e-mailing her husband about her experiences, and the message somehow turned into verse. The poem became the basis for her memoir "Rule Number Two: Lessons I Learned in a Combat Hospital" -- lessons that she revisited last week following the shooting at a combat stress facility in Baghdad. Kraft, who left active duty after nine years in the Navy and now treats combat stress patients, spoke with Outlook's Rachel Dry about how the military handles mental health and why PTSD can be like a sprained ankle. Excerpts:

Last Monday, Sgt. John M. Russell allegedly walked into a combat stress facility at Camp Liberty in Baghdad and opened fire, killing five service members. What did you think when you heard about the shooting?

My heart sank. I was so terribly saddened to hear it. As a provider, I can understand how something like this might have happened. Certainly if someone expresses either suicidal or homicidal thoughts, that person is categorized as a psychiatric emergency and steps are taken to stabilize that person. Sometimes those thoughts are not expressed in a way that makes it very clear what you're dealing with, and sometimes there's nothing to be done.

READ MORE @ WASHINGTON POST

Saturday, May 16, 2009

Cardiac Risks Hold Up Approval of Two Antipsychotics

FDA advisors remain skeptical about the safety of two antipsychotics for which regulatory approval is being sought and are especially troubled by potentially fatal cardiac risks.

Despite positive efficacy data from placebo-controlled trials, experts on a Food and Drug Administration (FDA) psychopharmacology advisory committee have reservations about potentially dangerous adverse effects of two antipsychotic medications under regulatory review for approval.

The FDA held meetings in April to seek the committee's advice on whether sertindole, a second-generation antipsychotic (SGA), should be approved for the treatment of schizophrenia and prevention of suicide in schizophrenia patients, and whether quetiapine XR extended-release tablets should be approved for treating major depressive disorder (MDD) as a monotherapy and as an adjunctive therapy to an antidepressant and for treating generalized anxiety disorder (GAD) as a monotherapy.

READ MORE @ PSYCHIATRIC TIMES

Friday, May 15, 2009

The Psychological Toll of Early Onset Alzheimer's Disease

Lisa Carbo knew something was wrong. The former registered nurse from Metairie, La., began experiencing difficulty in remembering how to perform various functions at her job. Multitasking became harder. Eventually she was written up for poor performance, prompting her to seek medical help.

Carbo was diagnosed with early onset Alzheimer's disease in November 2007, at the age of 53.

Before her Alzheimer's diagnosis, Carbo had plans for her golden years. "I hoped to semi-retire, spend the rest of [my] life with someone, continue to be productive, travel," she said. "I love animals, I had planned to do a lot more volunteering with animal shelters."

Her diagnosis changed everything: She lost her job and her boyfriend left her. "All those hopes and dreams are smashed. They're all gone. It's like everything that you planned on for your life is gone."

Fortunately for Carbo, she was able to find help to deal with the depression brought about by her diagnosis. She began taking antidepressants and started seeing a therapist.

READ MORE @ ABC NEWS

Thursday, May 14, 2009

Antidepressants: Brand Name or Generic?

For many antidepressants, the issue of brand-name versus generic has no practical significance. Elavil was first marketed almost a half century ago, and its patent has long expired. It lives on, however, but as generic amitriptyline. Today, only a few antidepressants are still fully protected by patents, namely, Cymbalta (2010), Lexapro (2012), and Pristiq (2022) for major depressive disorder (MDD); and Seroquel (2011) and Symbyax (2017) for bipolar depression.

The issue of brand-name versus generic, however, is far more complex than merely listing patent expiration dates. Patents can be extended, challenged, and infringed on; financial considerations are enormous; and patient care issues are often of central importance. To place antidepressants in proper perspective, it is first necessary to provide some general background about patents and drug regulation.

READ MORE @ PSYCHIATRIC TIMES

Wednesday, May 13, 2009

Role of Acupuncture in the Treatment of Depression Benefits and Limitations of Adjunctive Treatment and Monotherapy

Acupuncture is being integrated into Western medicine, particularly for treatment of pain, nausea, asthma, and neurological conditions.1 Although the exact mechanism of action for acupuncture is unknown, it is associated with an increase in the level of neurobiologically active substances, such as endorphins and enkephalins.2 There are also data indicating that acupuncture induces the release of norepinephrine, serotonin, and dopamine.3-5

ADVERSE EFFECTS

Acupuncture is well tolerated compared with tricyclic antidepressant medications.6-9 Adverse effects are mild and transient and include tiredness, drowsiness, exacerbation of primary symptoms, and itching in the area of acupuncture.10 Complications such as pneumothorax, infection, cardiac conditions, and spinal cord injury are extremely rare.10

AVAILABLE DATA

The number of studies of Western acupuncture in the treatment of depression and conditions associated with depression is limited.10 Even fewer reports provide objective data to support efficacy (eg, neurotransmitter) level change, imaging studies, and electroencephalographic alterations. Only 7 randomized comparative studies have been published, even though the first attempts to compare acupuncture with conventional treatments for depression began in the 1970s.

READ MORE @ PSYCHIATRIC TIMES

Tuesday, May 12, 2009

Participants in antidepressant drug trials are atypical patients, UT Southwestern researchers report

One reason antidepressant medication treatments do not work as well in real life as they do in clinical studies could be the limited type of study participants selected, researchers at UT Southwestern Medical Center have found.

"We are basing our judgment of clinical care in the United States on samples of patients that are totally different from the patient population actually treated in primary care and mental health facilities," said Dr. Madhukar Trivedi, professor of psychiatry at UT Southwestern and senior author of a study published in the May issue of the American Journal of Psychiatry. "Antidepressants should not be seen as a panacea. The general belief is that they work well, but they are less effective in real-world practice, and more work is needed."

As part of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study scientists found that only 22 percent of the 2,855 participants treated with a commonly prescribed antidepressant would have met the criteria for inclusion in a typical antidepressant efficacy trial. Those who did meet criteria had shorter bouts of depression, quicker response to medication, less severe side effects and fewer adverse events compared with those people with depression who would have been excluded from such a trial, used to gain Food and Drug Administration approval of the drugs used.

The STAR*D trial was the first large-scale study to define the effectiveness of several treatment steps in primary care and mental health settings for people with depression, Dr. Trivedi said.

The six-year, $35 million STAR*D study is the largest investigation on the treatment of major depressive disorder and is considered a benchmark in the field of depression research. It initially included more than 4,000 people from outpatient treatment sites across the country. About 65 percent of STAR*D participants, however, had a medical co-morbidity such as diabetes that typically would have excluded them from participating in other clinical trials to test the efficacy of antidepressants, said Dr. Trivedi, co-principal investigator of STAR*D.

READ MORE @ EUREKAERT

Monday, May 11, 2009

Antidepressants: The right people aren't always getting them

The medications are widely used to treat complaints such as loneliness or low energy. Meanwhile, studies say many with depression go untreated.

It was just over 20 years ago that the antidepressant Prozac was first approved by the U.S. Food and Drug Administration. The medication was touted as nothing short of a miracle: Not only was it was highly effective in treating depression, it also caused very few side effects.

The drug's popularity grew rapidly, and pharmaceutical companies got busy developing a variety of other, chemically similar antidepressants, collectively referred to as selective serotonin reuptake inhibitors (or SSRIs). There are at least half a dozen SSRIs on the market, including Lexapro, Paxil, Zoloft, Celexa and Luvox.

Since the introduction of these drugs, the number of Americans being treated for depression has increased dramatically; the Centers for Disease Control and Prevention says antidepressants are the most commonly prescribed medication in the country. But it's not always the right people taking them. Some who probably have very little to gain from their use are on SSRIs; others who stand to benefit are not.

READ MORE @ LOS ANGELES TIMES

Sunday, May 10, 2009

Women Stopping Antidepressant Medication For Premenstrual Syndrome Experience Relapse

A report in the May issue of the Archives of General Psychiatry (one of the JAMA/Archives journals) indicates that many women take the antidepressant called sertraline to relieve severe premenstrual symptoms, and it seems that half of them go through relapse after six to eight months after stopping the medication. There is a higher probability of relapse for women with more severe symptoms and those who consumed the drug during a shorter period.

Background facts sustained in the report demonstrate that premenstrual syndrome (PMS) is one of the most frequent health problems among women of reproductive age. Sertraline hydrochloride and other antidepressant medications are approved to treat PMS when it is most severe, also known as premenstrual dysphoric disorder (PMDD).

The authors explain: "There is little information about the optimal duration of treatment, although anecdotal reports and small pilot investigations suggest that premenstrual symptoms return rapidly in the absence of effective medication."

READ MORE @ MEDICAL NEWS TODAY

Saturday, May 9, 2009

Is The FDA Easing Up? How one company turned a rejection into a thumbs up, and what it could mean for the drug industry as a whole.

After the Food and Drug Administration told Vanda Pharmaceuticals that the company's schizophrenia drug was "not approvable" last July, Wall Street marked the tiny biotech for dead.

The FDA asked for a new clinical trial; Vanda insisted it could change the agency's mind with its existing data. Its shares sank from $4 to 45 cents. A hedge fund, Tang Capital Partners, started a proxy fight to try and get Vanda to liquidate and distribute the proceeds to shareholders.

Then Wednesday night, the FDA announced it was approving the drug, Fanapt, based on data from 3,000 patients. Vanda shares exploded 700% to $8. That's the kind of jackpot that could start getting investors interested in gambling on tiny biotechs again.

But the Vanda story may signal something far more important for investors than just a reminder that biotech stocks can pop: an easier FDA. Both Wyeth ( WYE - news - people ), which is being bought by Pfizer ( PFE - news - people ), and Schering-Plough ( SGP - news - people ), which is being bought by Merck ( MRK - news - people ), were rebuffed last year by the FDA after submitting data for schizophrenia drugs.

READ MORE @ FORBES

Friday, May 8, 2009

More Americans taking drugs for mental illness

Many more Americans have been using prescription drugs to treat mental illness since 1996, in part because of expanded insurance coverage and greater familiarity with the drugs among primary care doctors, U.S. researchers said on Tuesday.

They said 73 percent more adults and 50 percent more children are using drugs to treat mental illness than in 1996.

Among adults over 65, use of so-called psychotropic drugs -- which include antidepressants, antipsychotics and Alzheimer's medicines -- doubled between 1996 and 2006.

"What we generally find is there has been an increase in access to care for all populations," said Sherry Glied of Columbia University in New York, whose study appears in the journal Health Affairs.

READ MORE @ REUTERS

Thursday, May 7, 2009

For Old Drugs, New Tricks - Advice Veers Away From Flushing Unused Pills

At the Leesburg Pharmacy, located in a Loudoun County strip mall, a big, round fish tank sits atop the prescription counter. There are no fish inside, not even any water: The tank is a repository for unused medications. People can drop off the Vicodin that didn't get used once the pain of a root canal subsided. Or the heart pills remaining after a grandmother's death. Or an asthma inhaler that had passed its expiration date. Or an antidepressant that turned out to have unpleasant side effects.

Once a week, the tank is emptied; the drugs are packed in cartons by pharmacy personnel and ultimately incinerated by a commercial waste firm.

"Our customers are thrilled because they had no idea what else to do with this stuff," said Cheri Garvin, chief executive of the employee-owned pharmacy.

These are customers who are trying to do the responsible thing. Over the years, Americans have been alerted to the dangers of a lot of problematic waste materials -- paint thinner, batteries, air conditioners. But leftover pills can seem so small, so easily disposable, that many people routinely flush them down toilets, wash them down sinks or throw them in trash that goes to a landfill.

And then they often end up in places where they shouldn't be, like the public water supply.

The average American takes more than 12 prescription drugs annually, with more than 3.8 billion prescriptions purchased each year, according to the Kaiser Family Foundation. The most commonly cited estimates from Environmental Protection Agency researchers say that about 19 million tons of active pharmaceutical ingredients are dumped into the nation's waste stream every year.

READ MORE @ WASHINGTON POST

Wednesday, May 6, 2009

Why Antidepressants Don't Live Up to the Hype

In the '90s, Americans grew fond of the idea that you can fix depression simply by taking a pill — most famously fluoxetine (better known as Prozac), though fluoxetine is just one of at least seven selective serotonin reuptake inhibitors (SSRIs) that have been prescribed to treat hundreds of millions of people around the world.

But in the past few years, researchers have challenged the effectiveness of Prozac and other SSRIs in several studies. For instance, a review published in the Journal of Affective Disorders in February attributed 68% of the benefit from antidepressants to the placebo effect. Likewise, a paper published in PLoS Medicine a year earlier suggested that widely used SSRIs, including Prozac, Effexor and Paxil, offer no clinically significant benefit over placebos for patients with moderate or severe depression. Meanwhile, pharmaceutical companies maintain that their research shows that SSRIs are powerful weapons against depression. (Here's a helpful blog post that summarizes the debate.)

Now a major new study suggests that both critics and proponents might be right about SSRIs: the drugs can work, but they appear to work best for only a subset of depressed patients — those with a limited range of psychological problems. People whose depression is compounded with, say, substance abuse or a personality disorder may not get much help from SSRIs — which is unfortunate for the 45% to 60% of patients in the U.S. who have been diagnosed with a common mental disorder like depression and also meet the criteria for at least one other disorder, like substance abuse. (Multiple diagnoses are known in medical parlance as comorbidities.)

READ MORE @ TIME

Tuesday, May 5, 2009

New Route To Treat Depression - Finding could help people failed by current antidepressants

A NEW TARGET for treating depression, discovered by researchers in Iowa, may offer an alternative to current antidepressants, which target other mechanisms to treat the condition.

"The mechanism issue is important because if a patient doesn't respond to one drug, the chances of them responding to another drug that works through the same mechanism are low," says John A. Wemmie, who led the research team. Wemmie is an associate professor of psychiatry and neurosurgery at the University of Iowa and a staff physician and researcher at the Iowa City Veterans Affairs Medical Center.

Wemmie's team focused on a biochemical pathway involving acid-sensing ion channel (ASIC) proteins expressed by neurons. ASICs are activated by protons that are believed to act as neurotransmitters (C&EN, Jan. 14, 2008, page 10). Wemmie and his colleagues concentrated on the ASIC1a class of these ion channels, which are abundant in regions of the brain associated with mood.

The research group had previously shown in mice that ASIC1a activity is associated with anxiety, which often accompanies depression. In the new work, the researchers showed that mice lacking the gene for ASIC1a were less susceptible than normal mice to depression caused by stress. In a second experiment, the researchers treated normal mice with A-317567, an experimental ASIC inhibitor that Abbott Laboratories has been studying for pain treatment. Wemmie's team reports that blocking ASIC1a in this way produced antidepressant effects in the animals (J. Neurosci. 2009, 29, 5381).

READ MORE @ CHEMICAL & ENGINEERING NEWS

Monday, May 4, 2009

AAN: Atypical Antipsychotic Reduces Autism Irritability

Aripiprazole (Abilify) may be effective off-label for treating the irritability associated with autism, researchers here said.

The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.

It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.

Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.

Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.

But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.

READ MORE @ MEDPAGE TODAY

Sunday, May 3, 2009

Drugs 'can help mild depression'

Antidepressants can help mild to moderate depression and should not just be used in bad cases, researchers say.

Current guidelines urge doctors to avoid antidepressants as an initial treatment in mild depression.

But an NHS-funded study of 200 patients from across England found the drugs, called SSRIs, were more effective than GP advice and support alone.

The team hope national advisers will look at their findings, reported on the Health Technology Assessment website.

Study leader Professor Tony Kendrick, a GP and researcher at the University of Southampton, said although the National Institute of Health and Clinical Excellence wants doctors to restrict SSRIs to the most severe cases, GPs frequently prescribe them for milder cases.

"Just because someone has mild depression does not mean it is a mild illness, because it can cause them to be off work for months," he said.

"And often you don't have psychological treatments to offer because they're not available so you end up prescribing quite frequently."

READ MORE @ BBC

Saturday, May 2, 2009

Researchers find common genetic variations in autistic people

Findings show that many autistic people have a deviation in a portion of their DNA that affects the way brain cells connect with one another. The discovery may lead to treatments.

Researchers have found that many people with autism share common genetic variations, a discovery that may improve diagnosis and offers the promise of developing treatments for the frustratingly mysterious disorder.

Their findings, published in the journal Nature, compared the genomes of thousands of autistic people with those of thousands of people without the disorder -- a massive task that new technology has only recently made possible. The genome is the complex system of DNA coding that builds and runs the human body.

The review showed that most autistic people examined have a genetic variation in a portion of their DNA that affects the way brain cells connect with one another. Scientists also reported a link between autism and small "mistakes" in another DNA segment involved with cell communication. Both reports add weight to the idea that autism is related to problems with the way brain cells connect.

READ MORE @ LOS ANGELES TIMES

Friday, May 1, 2009

Off-Label Prescribing

Medications cannot be marketed in the United States without an FDA determination that they are safe and effective for their intended use. To obtain such certification, pharmaceutical companies submit their products to rigorous scrutiny (eg, in vitro studies, animal studies, human clinical trials) and present the subsequent data to the FDA, which determines whether the medication in question is safe and effective for a specific purpose. FDA approval comes with specific labeling requirements for the product, including the approved indications for use, the appropriate dosing, and the specific populations for its use. Once a medication has been approved for a specific use, physicians and other prescribers are permitted to prescribe the medication for conditions not covered by the approved use.

Several recent studies have dem­onstrated that off-label prescribing is very common among physicians, particularly among psychiatrists. Legal scholars have estimated that approximately 40% to 60% of prescriptions are for off-label use.1 In one important study, researchers examined office-based prescribing patterns for 160 commonly prescribed medications and determined that approximately 21% were for off-label use. In this study, off-label use was most common for cardiac medications (46%), anticonvulsant medications (46%), and asthma medications (42%). The investigators also found that most off-label use (73%) had limited or no scientific support.

The greatest disparity in the percentage of scientifically supported versus unsupported off-label use occurred with psychiatric medications. In 96%, the off-label use was determined to have little or no sound scientific evidence for the condition for which the drug was prescribed.2

READ MORE @ PSYCHIATRIC TIMES