Amisulpride in Schizophrenic Acute Phase Patients (ASAP)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Amisulpride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436371

L_9517

Details and patient eligibility

About

To collect the safety and response of using Amisulpride in acute schizophrenic patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode

Exclusion criteria

• Patients previously treated with amisulpride
• Patients have comorbidity which may interfere with the treatment or follow-up
• Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
• Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse
• Pregnant or lactation

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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1

Experimental group

Description:

Amisulpride 400-800mg per day on a twice-a-day regimen

Treatment:

Drug: Amisulpride