The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8-week, prospective, open-label, multicenter, single-arm study

Asia Pac Psychiatry. 2016 Sep;8(3):241-4. doi: 10.1111/appy.12238. Epub 2016 Mar 28.

Abstract

Introduction: This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients.

Methods: A multicenter, single-arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8.

Results: A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events.

Discussion: Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia.

Keywords: Chinese; Schizophrenia; amisulpride; antipsychotic agents/adverse effects; antipsychotic agents/therapeutic use.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Amisulpride
  • Antipsychotic Agents / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Schizophrenia / drug therapy*
  • Sulpiride / analogs & derivatives*
  • Sulpiride / therapeutic use
  • Treatment Outcome
  • Young Adult

Substances

  • Antipsychotic Agents
  • Sulpiride
  • Amisulpride