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NCT00436371 Clinical Trial

Amisulpride in Schizophrenic Acute Phase Patients

Schizophrenia Clinical Trial

— ASAP  

Official title:
The Use of Amisulpride in Schizophrenic Acute Phase Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00436371
Other study ID # L_9517
Secondary ID
Status Completed
Phase Phase 4
First received February 15, 2007
Last updated September 4, 2008
Start date May 2005

Study information
Verified date September 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 3 months) withdrawn from drug or alcohol abuse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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Amisulpride
Oral tablets

Locations
Country Name City State
Hong Kong Sanofi-Aventis Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events all across the study No
Secondary Clinical Global Impressions All accross the study No
Secondary Patient compliance all across the study No
Secondary Percentage of patient completing treatment all across the study No
Secondary Changes in body weight At baseline and day 84 No
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