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Background Episodes of depression are the most frequent cause of disability among patients with bipolar disorder. The effectiveness and safety of standard antidepressant agents for depressive episodes associated with bipolar disorder (bipolar depression) have not been well studied. Our study was designed to determine whether adjunctive antidepressant therapy reduces symptoms of bipolar depression without increasing the risk of mania.
Methods In this double-blind, placebo-controlled study, we randomly assigned subjects with bipolar depression to receive up to 26 weeks of treatment with a mood stabilizer plus adjunctive antidepressant therapy or a mood stabilizer plus a matching placebo, under conditions generalizable to routine clinical care. A standardized clinical monitoring form adapted from the mood-disorder modules of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, was used at all follow-up visits. The primary outcome was the percentage of subjects in each treatment group meeting the criterion for a durable recovery (8 consecutive weeks of euthymia). Secondary effectiveness outcomes and rates of treatment-emergent affective switch (a switch to mania or hypomania early in the course of treatment) were also examined.
Results Forty-two of the 179 subjects (23.5%) receiving a mood stabilizer plus adjunctive antidepressant therapy had a durable recovery, as did 51 of the 187 subjects (27.3%) receiving a mood stabilizer plus a matching placebo (P=0.40). Modest nonsignificant trends favoring the group receiving a mood stabilizer plus placebo were observed across the secondary outcomes. Rates of treatment-emergent affective switch were similar in the two groups.
Conclusions The use of adjunctive, standard antidepressant medication, as compared with the use of mood stabilizers, was not associated with increased efficacy or with increased risk of treatment-emergent affective switch. Longer-term outcome studies are needed to fully assess the benefits and risks of antidepressant therapy for bipolar disorder. (ClinicalTrials.gov number, NCT00012558
[ClinicalTrials.gov]
.)
Source Information
From Massachusetts General Hospital, Harvard Medical School (G.S.S., A.A.N., M.J.O.), and Boston University (M.W.O.) — all in Boston; Case Western Reserve University–University Hospitals Case Medical Center, Cleveland (J.R.C.); Baylor College of Medicine and South Central Mental Illness Research Education and Clinical Core — both in Houston (L.B.M., J.M.M.); the University of Pittsburgh (S.R.W.) and University of Pittsburgh School of Medicine (E.S.F., M.E.T.) — both in Pittsburgh; the University of Pennsylvania, Philadelphia (L.G.); the University of Texas Health Science Center, San Antonio (C.L.B.); the University of Oklahoma College of Medicine–Tulsa, Tulsa (M.D.F.); Stanford University School of Medicine, Stanford, CA (T.A.K.); the University of Massachusetts Medical School, Worcester (J.P.); the Portland Veterans Affairs Medical Center and Oregon Health and Sciences University — both in Portland (P.H.); the University of Toledo College of Medicine, Toledo, OH (D.R.); the University of Colorado Health Sciences Center, Denver (M.H.A.); the University of Colorado, Boulder, and University of Colorado Health Sciences Center, Boulder (D.J.M.); and Purdue University, West Lafayette, IN (E.B.D.).
This article (10.1056/NEJMoa064135) was published at www.nejm.org on March 28, 2007.
Address reprint requests to Dr. Sachs at the Bipolar Clinic and Research Program, Massachusetts General Hospital, 50 Staniford St., Suite 580, Boston, MA 02114, or at gsachs{at}partners.org.
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