Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Sanofi316 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

316

Conditions

Schizophrenia

Interventions

AMISULPRIDEDRUG

Pharmaceutical form: tablet Route of administration: oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Beijing, China

Outcomes

Primary Outcomes

Effective percentage (PANSS score reduced rate≥50%)

Time frame: Week 8

Secondary Outcomes

Early response rate (PANSS score reduced rate: at least 20%)

Time frame: week 2

Positive and Negative Syndrome Scale (PANSS)-total score improvement

Time frame: Baseline, Week 8

Clinical Global Impression Scale- Improvement (CGI-I)

Time frame: Baseline, Week 8

Data from ClinicalTrials.gov

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