Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia (ESCAPE)

January 21, 2015 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

316

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: AMISULPRIDE
Pharmaceutical form: tablet Route of administration: oral
Other Names:
  • Solian

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effective percentage (PANSS score reduced rate≥50%)
Time Frame: Week 8
Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 18, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMISUL06155
  • U1111-1131-0692 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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