SOLIACS: Solian Solution in the Acute Setting
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00245674
Collaborator
(none)
300
1
Study Details
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.
| 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:
Solian Solution to Treat Schizophrenic Patients During an Acute Episode
Study Start Date
:
Jun 1, 2005
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-aventis | Diegem | Belgium |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Dr. Christian Fassotte, M.D., Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00245674
Other Study ID Numbers:
- PM_L_0055
- EudraCT # : 2004-004461-15
First Posted:
Oct 28, 2005
Last Update Posted:
Apr 10, 2008
Last Verified:
Apr 1, 2008