SOLIACS: Solian Solution in the Acute Setting

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. Identifier: NCT00245674
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : April 10, 2008
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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
Schizophrenia Drug: amisulpride Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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 : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. *analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.

Secondary Outcome Measures :
  1. *analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245674

Diegem, Belgium
Sponsors and Collaborators
Study Director: Dr. Christian Fassotte, M.D. Sanofi Identifier: NCT00245674     History of Changes
Other Study ID Numbers: PM_L_0055
EudraCT # : 2004-004461-15
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action