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Editor: Robert Binstock
Profession: Paxil Side Effect Attorney

Category: Paxil News

Antidepressants, commonly prescribed with mood stabilizers to treat patients with bipolar, do not work to relieve depressive symptoms associated with the illness, according to a large federal study.

The study in the New England Journal of Medicine narrows down the limited number of bipolar treatments which affects 5.7 million adults in the United States, according to experts.

''A new generation of drugs is needed,'' said Dr. Thomas R. Insel, director of the National Institute of Mental Health. ''It is clear from this data that antidepressants are not the answer.''

Some doctors believe antidepressants could continue play a role because there are so few options available right now and the drugs do seem to alleviate other distressing systems often known to accompany bipolar disorder. People that suffer from bipolar disorder experience severe swings between mania and depression, marked by extreme energy and restlessness. Bipolar can interfere with day to day activities and in severe cases lead to suicide.

Researchers estimate 50 to 70 percent of people with bipolar take antidepressants, although the Food and Drug Administration has not approved these drugs as a treatment for the disorder.

The study, part of the NIMH's $27 million Systematic Treatment Enhancement Program for Bipolar Disorder, or STEP-BD, set out to determine whether common antidepressants Wellbutrin and Paxil would enhance the benefits of mood-stabilizer drugs. The study was also designed to find out if the antidepressants would trigger mania.

Previous studies had provided mixed results on their effectiveness. Wellbutrin and Paxil were chosen for the study because earlier studies indicated they were less likely to trigger mania than other antidepressants.

In the study, 366 patients at 22 academic centers in the U.S. were randomly assigned to receive one of the two antidepressants or a placebo pill for 26 weeks, in addition to their mood-stabilizers. Patients also received psychological and social therapy.

The study, designed to mimic real-world conditions, differed from a typical clinical trial in that many patients had complicating disorders, including anxiety, substance abuse or psychosis.

Of the 179 participants who received an antidepressant in addition to a mood stabilizer, 23.5 percent achieved a durable recovery, defined as an eight-week period marked by no more than two depressive or two manic symptoms. In the placebo group, 27.3 percent of patients achieved a durable recovery.

Researchers report there was no sign that Wellbutrin and Paxil would trigger a manic episode. They believe 10.1 percent of patients on antidepressants and 10.7 percent of those on placebo exhibited manic symptoms.

The study should help guide the way for new patients and how they are treated. For patients already taking antidepressants and doing well,t here is no reason to quit.