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Randomised controlled trial.
Twenty outpatient centres, USA; time period not stated.
116 child and adolescent outpatients (aged 7–18 years) with DSM-IV bipolar I disorder (confirmed by Schedule for Affective Disorders and Schizophrenia for School Age Children – Present and Lifetime Version), and experiencing a manic or mixed episode (baseline score ⩾ 20 on the Young Mania Rating Scale (YMRS)). Exclusions: current primary DSM-IV schizophrenia, delirium, substance induced mood disorder, anorexia, bulimia, or autism; …
For correspondence: Dr Karen D Wagner, Department of Psychiatry and Behavioral Sciences, University of Texas Medical Branch, 301 University Boulevard, Galveston, TX 77755-0188, USA;
Source of funding: Novartis Pharmaceuticals.
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