ASAP: Amisulpride in Schizophrenic Acute Phase Patients
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00436371
Collaborator
(none)
50
1
1
Study Details
Study Description
Brief Summary
To collect the safety and response of using Amisulpride in acute schizophrenic patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Amisulpride in Schizophrenic Acute Phase Patients.
Study Start Date
:
May 1, 2005
Actual Primary Completion Date
:
Nov 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Amisulpride 400-800mg per day on a twice-a-day regimen |
Drug: Amisulpride
Oral tablets
|
Outcome Measures
Primary Outcome Measures
- Adverse events [all across the study]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 3 months) withdrawn from drug or alcohol abuse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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Hong Kong | Hong Kong |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Elaine Tang, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00436371
Other Study ID Numbers:
- L_9517
First Posted:
Feb 19, 2007
Last Update Posted:
Sep 5, 2008
Last Verified:
Sep 1, 2008