Controlled, dose-response study of sertindole and haloperidol in the treatment of schizophrenia. Sertindole Study Group

TLDR

Sertindole is a novel antipsychotic that effectively treats both positive and negative symptoms of schizophrenia while producing motor side effects indistinguishable from placebo, with only mild adverse events reported. In this multicenter, double‑blind, placebo‑controlled trial, 497 hospitalized schizophrenia patients were randomized to receive three doses of sertindole (12, 20, 24 mg/day) or haloperidol (4, 8, 16 mg/day) for eight weeks, with efficacy assessed by PANSS, SANS, BPRS, and CGI scores and safety evaluated through extrapyramidal symptom scales and adverse event monitoring. Both drugs were comparably effective for psychosis, all doses outperformed placebo, but only sertindole 20 mg/day significantly improved negative symptoms; extrapyramidal symptoms were similar to placebo for sertindole and dose‑independent, whereas haloperidol produced markedly higher extrapyramidal rates, and adverse events with sertindole were mild.

Abstract

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.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.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.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 placebo.