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OpenTrials
Completed

NCT Number: NCT01795183

Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Beijing, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amisulpride

Drug

Pharmaceutical form: tablet Route of administration: oral

Other names: Solian

Primary outcomes

  1. Effective percentage (PANSS score reduced rate≥50%)

    Time frame: Week 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: ESCAPE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2013
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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