Amisulpride in Schizophrenic Acute Phase Patients

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Amisulpride

• Registration Number: NCT00436371
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-11
• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-19
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-04
• Last Update Posted: 2008-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 3 months) withdrawn from drug or alcohol abuse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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Amisulpride	Amisulpride 400-800mg per day on a twice-a-day regimen

Primary Outcome Measures

Name	Time	Method
Adverse events	all across the study

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions	All accross the study
Patient compliance	all across the study
Percentage of patient completing treatment	all across the study
Changes in body weight	At baseline and day 84

Trial Locations

Locations (1)

Sanofi-Aventis; 🇭🇰 Hong Kong, Hong Kong