Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Schizophrenia Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795183
• Other study ID #: AMISUL06155
• Secondary ID: U1111-1131-0692
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2013
• Last updated: January 21, 2015
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• AMISULPRIDE
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
China	Sanofi-Aventis Administrative Office	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective percentage (PANSS score reduced rate=50%)		Week 8	Yes
Secondary	Early response rate (PANSS score reduced rate: at least 20%)		week 2	Yes
Secondary	Positive and Negative Syndrome Scale (PANSS)-total score improvement		Baseline, Week 8	Yes
Secondary	Clinical Global Impression Scale- Improvement (CGI-I)		Baseline, Week 8	Yes