NCT00245674

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

First QC Date

October 27, 2005

Last Update Submit

April 8, 2008

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

amisulprideDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • schizophrenic in-patients with an acute episode
  • aged between 18 and 65 years
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

Diegem, Belgium

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Dr. Christian Fassotte, M.D.

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

June 1, 2005

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

BE(1)