Back to resultsSOLIACS: Solian Solution in the Acute Setting
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
amisulpride
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: schizophrenic in-patients with an acute episode aged between 18 and 65 years written informed consent Exclusion Criteria: pregnancy and breast-feeding breast cancer, prolactinoma, pheochromocytoma hypersensitivity to amisulpride or one of the other excipients contra-indications when using amisulpride as per the SmPC
Sites / Locations
- Sanofi-aventis
Outcomes
Primary Outcome Measures
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
Secondary Outcome Measures
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00245674
Brief Title
SOLIACS: Solian Solution in the Acute Setting
Official Title
Solian Solution to Treat Schizophrenic Patients During an Acute Episode
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode.
The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.
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
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amisulpride
Primary Outcome Measure Information:
Title
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
Secondary Outcome Measure Information:
Title
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
schizophrenic in-patients with an acute episode
aged between 18 and 65 years
written informed consent
Exclusion Criteria:
pregnancy and breast-feeding
breast cancer, prolactinoma, pheochromocytoma
hypersensitivity to amisulpride or one of the other excipients
contra-indications when using amisulpride as per the SmPC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Christian Fassotte, M.D.
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis
City
Diegem
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
SOLIACS: Solian Solution in the Acute Setting
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