Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia

Secondary Objective:

To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Amisulpride; Sulpiride; Sultopride

Criteria

Inclusion criteria :

• Satisfying International Classification of Disease-10 (ICD) diagnostic criteria of schizophrenia;

• Positive and Negative Syndrome Scale (PANSS) total score ≥ 60

Exclusion criteria:

• Refractory schizophrenia or Patients treated with sufficient clozapine for a minimum period of 6-8 weeks without improvement;

• Participation into another clinical trial within the last month;

• Patients previously or currently treated with amisulpride;

• Patients receiving clozapine within the past 1 month or treated with long-acting formulation of antipsychotic medication within the past 2 months;

• Patients receiving electric convulsive therapy or physical therapy within the past 1 month;

• Patients with coexisting severe systemic diseases;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.