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Combined olanzapine plus fluoxetine modestly improves symptoms of acute bipolar I depression compared to lamotrigine

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Q What is the efficacy and safety of combined olanzapine plus fluoxetine compared with lamotrigine in bipolar I depression?

METHODS

Embedded ImageDesign:

Randomised controlled trial.

Embedded ImageAllocation:

Unclear.

Embedded ImageBlinding:

Double blind.

Embedded ImageFollow up period:

Seven weeks (treatment period only).

Embedded ImageSetting:

Thirty eight sites in the US; November 2003 to August 2004.

Embedded ImagePatients:

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 …

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