Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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

Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

AMISULPRIDE

Intervention Type DRUG

Pharmaceutical form: tablet Route of administration: oral

Interventions

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AMISULPRIDE

Pharmaceutical form: tablet Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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Solian

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No