SOLIACS: Solian Solution in the Acute Setting

Sanofi

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: amisulpride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245674

PM_L_0055

EudraCT # : 2004-004461-15

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)