作者: Gary S Sachs , Andrew A Nierenberg , Joseph R Calabrese , Lauren B Marangell , Stephen R Wisniewski
DOI: 10.1056/NEJMOA064135
关键词: Paroxetine 、 Bupropion 、 Bipolar disorder 、 Hypomania 、 Mood 、 Internal medicine 、 Placebo 、 Medicine 、 Mania 、 Psychiatry 、 Mood stabilizer
摘要: �Background Episodes of depression are the most frequent cause disability among patients with bipolar disorder. The effectiveness and safety standard antidepressant agents for depressive episodes associated disorder (bipolar depression) have not been well studied. Our study was designed to determine whether adjunctive therapy reduces symptoms without increasing risk mania. Methods In this double-blind, placebo-controlled study, we randomly assigned subjects receive up 26 weeks treatment a mood stabilizer plus or matching placebo, under conditions generalizable routine clinical care. A standardized monitoring form adapted from mood-disorder modules Structured Clinical Interview Diagnostic Statistical Manual Mental Disorders, fourth edition, used at all follow-up visits. primary outcome percentage in each group meeting criterion durable recovery (8 consecutive euthymia). Secondary outcomes rates treatment-emergent affective switch (a mania hypomania early course treatment) were also examined. Results Forty-two 179 (23.5%) receiving had recovery, as did 51 187 (27.3%) placebo (P = 0.40). Modest nonsignificant trends favoring observed across secondary outcomes. Rates similar two groups. Conclusions use adjunctive, medication, compared stabilizers, increased efficacy switch. Longer-term studies needed fully assess benefits risks (ClinicalTrials.gov number, NCT00012558.)