SOLIACS: Solian Solution in the Acute Setting

Sanofi300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Schizophrenia

Interventions

amisulprideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sanofi-aventis

Diegem, Belgium

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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