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Randomised controlled trial.
Forty one centres in the US; June 2004 to August 2005.
509 outpatients (18–65 years old) with DSM-IV bipolar I (n = 338) or II (n = 171) disorder experiencing a major depressive episode (17-item Hamilton Depression Rating Scale (HAM-D17) score ⩾20, HAM-D17 Item 1 score ⩾2; Young Mania Rating Scale score ⩽12). Participants were excluded if they had: been diagnosed with another Axis I disorder that had been treated within 6 months before the study; a current depressive episode lasting more than 12 months or less than 4 …
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