SOLIACS: Solian Solution in the Acute Setting

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amisulpride; Sultopride

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