Effectiveness of Adjunctive Antidepressant Treatment for Bipolar Depression  

Oleh:

Gary S., Sachs ; Nierenberg, Andrew A. ; Calabrese, Joseph R. ; Marangell, Lauren B ; Wisniewski, Stephen R. ; Gyulai, Laszlo ; Freidman, Edward S. ; Bowden, Charles L ; Fossey, Mark D. ; Ostacher, Michael J. ; Ketter, Terence A ; Patel, Jayendra ; Hauser, Peter ; Rapport, Daniel ; Martinez, James M. ; Allen, Michael H. ; Miklowitz, David J. ; Otto, Michael W. ; Dennehy, Ellen B ; Thase, Michael E.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 356 no. 17 (Apr. 2007), page 1711.

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K.2007.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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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 antide¬pressant 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 fol¬low-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 an¬tidepressant therapy had a durable recovery, as did 51 of the 187 subjects (27.3%) receiving a mood stabilizer plus a matching placebo (P=OAO). Modest nonsignifi¬cant 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. (ClinicaITrials.gov number, NCTOOO12558.)

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