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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01795183
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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
Schizophrenia Drug: AMISULPRIDE Phase 4

Detailed Description:
The study duration by subject will include a 8-week treatment period with 3 follow-up visits.
Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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 Name: Solian


Outcome Measures
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Primary Outcome Measures :
  1. Effective percentage (PANSS score reduced rate≥50%) [ Time Frame: Week 8 ]

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

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795183


Locations
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China
Sanofi-Aventis Administrative Office
Beijing, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01795183    
Other Study ID Numbers: AMISUL06155
U1111-1131-0692 ( Other Identifier: UTN )
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Amisulpride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents