OBJECTIVE: This multicenter, double-blind, placebo-controlled study
evaluated the efficacy and safety of three doses of sertindole (12, 20, and
24 mg/day) and haloperidol (4, 8, and 16 mg/day) in the treatment of
psychotic symptoms for 497 hospitalized patients with schizophrenia.
METHOD: The patients were randomly assigned to one of the medication groups
and received treatment for 8 weeks. Changes in Positive and Negative
Syndrome Scale, Scale for the Assessment of Negative Symptoms, Brief
Psychiatric Rating Scale, and Clinical Global Impression scores were used
as evaluations of treatment efficacy. Three rating scales were used to
assess extrapyramidal symptoms as well as the occurrence of adverse events
and the use of medications related to extrapyramidal symptoms. RESULTS:
Both sertindole and haloperidol were comparably effective in the treatment
of psychosis, and all dose levels were significantly more effective than
placebo. For the treatment of negative symptoms, only sertindole, 20
mg/day, was significantly more effective than placebo. For all
extrapyramidal symptom measures, sertindole was clinically and
statistically indistinguishable from placebo, and rates of extrapyramidal
symptoms were not dose related. All dose levels of haloperidol produced
significantly more extrapyramidal symptoms than placebo or sertindole.
Adverse events associated with sertindole treatment were mild in severity.
CONCLUSIONS: Sertindole is a new antipsychotic agent effective for the
treatment of both the positive and negative symptoms of schizophrenia, with
motor side effects that are indistinguishable from those associated with