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SOLIACS: Solian Solution in the Acute Setting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245674
First Posted: October 28, 2005
Last Update Posted: April 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
October 27, 2005
October 28, 2005
April 10, 2008
June 2005
Not Provided
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
Not Provided
Complete list of historical versions of study NCT00245674 on ClinicalTrials.gov Archive Site
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
Not Provided
Not Provided
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SOLIACS: Solian Solution in the Acute Setting
Solian Solution to Treat Schizophrenic Patients During an Acute Episode

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
Drug: amisulpride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00245674
PM_L_0055
EudraCT # : 2004-004461-15
Not Provided
Not Provided
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Sanofi
Not Provided
Study Director: Dr. Christian Fassotte, M.D. Sanofi
Sanofi
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP