SOLIACS: Solian Solution in the Acute Setting

Phase 4

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00245674
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-10-27
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-28
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-08
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.

Secondary Outcome Measures

Name	Time	Method
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.

Trial Locations

Locations (1)

Sanofi-aventis; 🇧🇪 Diegem, Belgium