Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

The Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia - A Prospective Open-Label Multicenter Study

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.

The study duration by subject will include a 8-week treatment period with 3 follow-up visits.

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.