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SOLIACS: Solian Solution in the Acute Setting

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: October 27, 2005
Last updated: April 8, 2008
Last verified: April 2008

October 27, 2005
April 8, 2008
June 2005
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*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
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Complete list of historical versions of study NCT00245674 on Archive Site
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
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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.

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Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: amisulpride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
PM_L_0055, EudraCT # : 2004-004461-15
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Study Director: Dr. Christian Fassotte, M.D. Sanofi
April 2008

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