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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
  Purpose

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 Intervention Phase
Schizophrenia Drug: amisulpride Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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.

Estimated Enrollment: 300
Study Start Date: June 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00245674


Locations
Belgium
Sanofi-aventis
Diegem, Belgium
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Dr. Christian Fassotte, M.D. Sanofi
  More Information

ClinicalTrials.gov Identifier: NCT00245674     History of Changes
Other Study ID Numbers: PM_L_0055
EudraCT # : 2004-004461-15
First Submitted: October 27, 2005
First Posted: October 28, 2005
Last Update Posted: April 10, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sultopride
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