Completed

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

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What is being tested

AMISULPRIDE

Drug
Who is being recruted

Mental Disorders

+ Schizophrenia Spectrum and Other Psychotic Disorders

+ Schizophrenia

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 22, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01795183
Principal SponsorSanofi
Last updated: January 22, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

316 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophrenia Spectrum and Other Psychotic DisordersSchizophrenia

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sanofi-Aventis Administrative Office

Beijing, ChinaOpen Sanofi-Aventis Administrative Office in Google Maps
CompletedOne Study Center