SOLIACS: Solian Solution in the Acute Setting

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00245674
First received: October 27, 2005
Last updated: April 8, 2008
Last verified: April 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Solian Solution to Treat Schizophrenic Patients During an Acute Episode

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Sanofi-aventis
Diegem, Belgium
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Dr. Christian Fassotte, M.D. Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00245674     History of Changes
Other Study ID Numbers: PM_L_0055, EudraCT # : 2004-004461-15
Study First Received: October 27, 2005
Last Updated: April 8, 2008
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sultopride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014