A Randomized, Double-blind, Comparison of the Efficacy and Safety of Amisulpride Versus Low-dose Amisulpride Plus Low-dose Sulpiride in the Treatment of Schizophrenia

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Surveys have shown that antipsychotic drug combinations are frequently prescribed. Amisulpride, an atypical antipsychotic agent, has low incidence of extrapyramidal symptom (EPS) but with high cost compared to sulpiride. The objective of the study is to compare the efficacy and safety of the 800-mg/d amisulpride and 400-mg/d amisulpride plus 800-mg sulpiride in the treatment of acute psychotic exacerbations of schizophrenia.

Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800 mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
• Treatments: Amisulpride; Sulpiride; Sultopride

Criteria

Inclusion Criteria:

• schizophrenia

• CGI >=4

• washout of antipsychotics at least 3-5 days

• written informed consents

Exclusion Criteria:

• History of serious adverse events to sulpiride or amisulpride

• History of neuroleptic malignant syndrome or tardive dyskinesia to antipsychotics

• treatment-resistant schizophrenia

• long-acting antipsychotics in the past 3 months

• comorbid with substance abuse/dependence

• female subjects with pregnancy

• severe physical illness