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Randomised controlled trial.
Follow up period:
Eight hospitals, India. Recruitment: March 2001 to December 2001.
291 people (aged 18–65 years) with bipolar I disorder (manic or mixed) (DSM-IV; Young Mania Rating Scale (YMRS)). Exclusions: YMRS score <20; no previous history of mania; schizoaffective disorder; rapid cycling bipolar disorder; borderline or antisocial personality disorder; neuroleptic malignant syndrome; substance abuse or dependence; …
For correspondence: Srihari Gopal, Forest Research Institute, Harborside Financial Plaza V, Jersey City, NJ 07311, USA;
Sources of funding: Johnson & Johnson Pharmaceutical Research and Development and National Institute of Health, USA.
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