April 3, 2007
Antidepressants, which are widely prescribed with mood stabilizers to treat patients with bipolar disorder, do not work in relieving the depressive symptoms of the illness, a large federal study reported Wednesday.
The study in the New England Journal of Medicine narrows the already limited number of treatments for bipolar disorder, which affects 5.7 million adults in the U.S., experts said.
‘’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.'’
Still, some doctors said antidepressants would continue to have a role because there are so few options, and the drugs seem to alleviate other distressing symptoms that often accompany the disorder.
‘’Many people we see are refractory to a mood stabilizer alone and adding an antidepressant markedly improves them,'’ said Dr. Lori Altshuler, professor of psychiatry at the University of California, Los Angeles, who was not involved in the study.
But Altshuler, who has consulted for companies that market drugs for psychological disorders, said the study clearly demonstrated that patients should first try a mood stabilizer, which can also have antidepressant effects.
People with bipolar disorder experience severe mood swings between depression and mania, a state marked by an excess of energy and restlessness. Symptoms of the disorder can interfere with daily activities, and severe cases carry a risk of suicide.
Standard treatment consists of mood stabilizers such as lithium, valproate and carbamazepine. Antidepressants are often added to control severe depressive swings, despite concerns the drugs might trigger a switch to a manic episode.
Researchers estimated that 50 percent to 70 percent of people with bipolar disorder take antidepressants, although the Food and Drug Administration has approved none of the 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.
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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.
The difference between the groups was not statistically significant, researchers said.
The criteria of durable recovery was stricter than other trials, which used rating systems to measure overall improvements in patients’ moods.
Researchers reported there was no sign that Wellbutrin or Paxil could trigger a manic episode. They said 10.1 percent of patients on antidepressants and 10.7 percent of those on placebo exhibited manic symptoms.
Lead author Dr. Gary Sachs, director of the bipolar clinic at Massachusetts General Hospital, said the study should guide the way new patients were treated, but there was no need for patients doing well on antidepressants to quit taking them.
But in an editorial accompanying the report, Dr. Robert H. Belmaker of Ben Gurion University in Beersheva, Israel, said the study would not settle debates about the safety and efficacy of antidepressants in treatment of bipolar disorder.
Patients who became manic in response to antidepressants in the past would not have enrolled in the trial, he said, casting doubt on whether the drugs are safe for all bipolar patients.
Belmaker noted that two European reviews of published studies found antidepressants to be highly effective and that in his practice he prescribes antidepressants to patients with severe depression but mild mania.
He said bipolar disorder is a heterogenous disorder that shows variability in symptoms, which argues for flexibility in treatment.
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