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To determine the safety and efficacy of sertindole compared with haloperidol and placebo in patients with schizophrenia.
8 week randomised, double blind, placebo controlled trial.
43 psychiatric inpatient centres; 41 in the United States and 2 in Canada.
497 patients who were 18 to 65 years of age (mean age 39 y, 78% men) and had a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM), 3rd edition, revised or DSM-IV schizophrenia, no other primary psychiatric diagnoses, and a combined score of ≥ 8 on any 2 of the positive symptoms of the Brief Psychiatric Rating Scale (BPRS). Exclusion criteria were tardive dyskinesia, substance abuse, or confounding medical or neurological problems. 477 patients (96%) were included in the intention to treat …
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