Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: AMISULPRIDE

• Registration Number: NCT01795183
• Lead Sponsor: Sanofi

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 schizophrenia.

Detailed Description

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

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-18
• Study First Posted: 2013-02-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amisulpride	AMISULPRIDE	Patients are treated with Amisulpride referring to the dosage and usage section in Chinese Solian® PI. Amisulpride dosage is adjusted based on individual response and reaches the sufficiency within 1 week

Primary Outcome Measures

Name	Time	Method
Effective percentage (PANSS score reduced rate≥50%)	Week 8

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)-total score improvement	Baseline, Week 8
Early response rate (PANSS score reduced rate: at least 20%)	week 2
Clinical Global Impression Scale- Improvement (CGI-I)	Baseline, Week 8

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Beijing, China