March 30, 2007 — According to the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), a large placebo-controlled trial of community-dwelling patients with bipolar depression who were receiving mood stabilizers, adjunctive antidepressant therapy did not reduce symptoms of depression, but neither did it increase the risk for mania. These results are reported online in the March 28 Early Release issue of The New England Journal of Medicine and will appear in the April 26 print issue.
Lead author Gary S. Sachs, MD, from Massachusetts General Hospital in Boston, explained to Medscape, "One group of experts was saying 'When people get depressed, you should add an antidepressant,' and another group of experts was saying 'When you get depressed, if you do a really good job with a mood stabilizer, you don't need an antidepressant.' This study proved that the latter group was correct, and that it is perfectly reasonable to treat patients without the addition of antidepressant, as long as you are doing a good job with mood stabilizers."
Dr. Sachs and his team write that although antidepressants are effective in treating unipolar depression, data supporting their use in bipolar depression are scarce and not strong enough to guide clinical practice, and this raises concerns among some clinicians that these agents could increase the risk for new episodes of mania. Despite the lack of Food and Drug Administration approval of standard antidepressants for the treatment of bipolar depression, these agents are commonly added as an adjunct to mood stabilizers for these patients.
STEP-BD is sponsored by the National Institute of Mental Health and was designed to evaluate the effectiveness of treatments of bipolar disorder and provide results for routine clinical practice. The current report is from a controlled trial within STEP-BD.
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