SOLIACS: Solian Solution in the Acute Setting - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00245674

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 IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Amisulpride Sultopride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Solian Solution to Treat Schizophrenic Patients During an Acute Episode

Further study details as provided by Sanofi-Aventis:

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245674

Locations

Belgium
Sanofi-aventis
Diegem, Belgium

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Dr. Christian Fassotte, M.D.

Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Study ID Numbers:	PM_L_0055, EudraCT # : 2004-004461-15
Study First Received:	October 27, 2005
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00245674
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders

Sultopride
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009