Back to resultsAmisulpride in Schizophrenic Acute Phase Patients (ASAP)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Amisulpride
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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 3 months) withdrawn from drug or alcohol abuse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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Amisulpride 400-800mg per day on a twice-a-day regimen
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Clinical Global Impressions
Patient compliance
Percentage of patient completing treatment
Changes in body weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436371
Brief Title
Amisulpride in Schizophrenic Acute Phase Patients
Acronym
ASAP
Official Title
The Use of Amisulpride in Schizophrenic Acute Phase Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
To collect the safety and response of using Amisulpride in acute schizophrenic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Amisulpride 400-800mg per day on a twice-a-day regimen
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
all across the study
Secondary Outcome Measure Information:
Title
Clinical Global Impressions
Time Frame
All accross the study
Title
Patient compliance
Time Frame
all across the study
Title
Percentage of patient completing treatment
Time Frame
all across the study
Title
Changes in body weight
Time Frame
At baseline and day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Tang
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Amisulpride in Schizophrenic Acute Phase Patients
We'll reach out to this number within 24 hrs