Status:
COMPLETED
Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia
Lead Sponsor:
Sanofi
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 sc...
Detailed Description
The study duration by subject will include a 8-week treatment period with 3 follow-up visits.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT01795183
Start Date
November 1 2012
End Date
December 1 2013
Last Update
January 22 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Beijing, China