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Q What is the efficacy and safety of combined olanzapine plus fluoxetine compared with lamotrigine in bipolar I depression?
Randomised controlled trial.
Follow up period:
Seven weeks (treatment period only).
Thirty eight sites in the US; November 2003 to August 2004.
410 adult outpatients or hospital inpatients with bipolar I depression (Structured Clinical Interview for DSM-IV); a total score of ⩾20 on the Montgomery-Asberg depression rating scale (MADRS); a score of ⩾4 (moderately ill) on the Clinical Global Impressions-Severity of Illness scale (CGI-S); and at least one previous manic or mixed episode that was severe enough to warrant treatment with a mood stabiliser or antipsychotic. Exclusions: current DSM-IV diagnosed mixed state; suicide risk; DSM-IV alcohol or substance abuse disorder in the preceding 30 days; Young Mania Rating Scale total score ⩾15; or previous non-response …
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