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ESCAPE: Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01795183
Collaborator
(none)
316
Enrollment
1
Location
1
Arm
13
Duration (Months)
24.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
316 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia - A Prospective Open-Label Multicenter Study
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effective percentage (PANSS score reduced rate≥50%) [Week 8]

    Secondary Outcome Measures

    1. Early response rate (PANSS score reduced rate: at least 20%) [week 2]

    2. Positive and Negative Syndrome Scale (PANSS)-total score improvement [Baseline, Week 8]

    3. Clinical Global Impression Scale- Improvement (CGI-I) [Baseline, Week 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sanofi-Aventis Administrative Office Beijing China

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01795183
    Other Study ID Numbers:
    • AMISUL06155
    • U1111-1131-0692
    First Posted:
    Feb 20, 2013
    Last Update Posted:
    Jan 22, 2015
    Last Verified:
    Jan 1, 2015
    Additional relevant MeSH terms:
    Schizophrenia
    Amisulpride

    Study Results

    No Results Posted as of Jan 22, 2015