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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
AMISULPRIDE
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amisulpride

Arm Description

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

Outcomes

Primary Outcome Measures

Effective percentage (PANSS score reduced rate≥50%)

Secondary Outcome Measures

Early response rate (PANSS score reduced rate: at least 20%)
Positive and Negative Syndrome Scale (PANSS)-total score improvement
Clinical Global Impression Scale- Improvement (CGI-I)

Full Information

First Posted
February 18, 2013
Last Updated
January 21, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01795183
Brief Title
Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia
Acronym
ESCAPE
Official Title
The Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia - A Prospective Open-Label Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amisulpride
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AMISULPRIDE
Other Intervention Name(s)
Solian
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Effective percentage (PANSS score reduced rate≥50%)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Early response rate (PANSS score reduced rate: at least 20%)
Time Frame
week 2
Title
Positive and Negative Syndrome Scale (PANSS)-total score improvement
Time Frame
Baseline, Week 8
Title
Clinical Global Impression Scale- Improvement (CGI-I)
Time Frame
Baseline, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28721051
Citation
Liang Y, Yu X. Effectiveness of amisulpride in Chinese patients with predominantly negative symptoms of schizophrenia: a subanalysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Jun 28;13:1703-1712. doi: 10.2147/NDT.S140905. eCollection 2017.
Results Reference
derived
PubMed Identifier
28461752
Citation
Liang Y, Yu X. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia who switch from risperidone or olanzapine: a subgroup analysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Apr 21;13:1163-1173. doi: 10.2147/NDT.S132363. eCollection 2017.
Results Reference
derived

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Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

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