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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: AMISULPRIDE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795183

AMISUL06155

U1111-1131-0692 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 316 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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316 participants in 1 patient group

Amisulpride

Experimental group

Description:

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

Treatment:

Drug: AMISULPRIDE