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Two randomised controlled trials.
Double blinded (clinicians, patients).
Follow up period:
Two identically designed trials run concurrently in 53 hospital, general practice and academic centres in USA, India, Canada, Costa Rica, and Mexico; enrolment December 1999 to May 2001.
376 children and adolescents aged 6 to 17 years with a current episode of MDD (DSM-IV criteria) lasting at least 6 weeks, and scoring at least 45 on the Children’s Depression Rating Scale-Revised (CDRS-R) and at least 4 on the Clinical Global Impression Scale of Severity of Illness (CGI-S) during 3 visits within a 2 week screening period. Exclusions: attention-deficit/hyperactivity disorder, conduct disorder, obsessive compulsive disorder, panic disorder, or psychotic features; history of bipolar, psychotic, or autistic spectrum …
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