Amisulpride in Schizophrenic Acute Phase Patients - Full Text View

Amisulpride in Schizophrenic Acute Phase Patients (ASAP)

This study has been completed.

First Received: February 15, 2007 Last Updated: September 4, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00436371

Purpose

To collect the safety and response of using Amisulpride in acute schizophrenic patients

Condition	Intervention	Phase
Schizophrenia	Drug: Amisulpride	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Sultopride Amisulpride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Use of Amisulpride in Schizophrenic Acute Phase Patients.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Adverse events [ Time Frame: all across the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impressions [ Time Frame: All accross the study ] [ Designated as safety issue: No ]
Patient compliance [ Time Frame: all across the study ] [ Designated as safety issue: No ]
Percentage of patient completing treatment [ Time Frame: all across the study ] [ Designated as safety issue: No ]
Changes in body weight [ Time Frame: At baseline and day 84 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2005
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Amisulpride 400-800mg per day on a twice-a-day regimen	Drug: Amisulpride Oral tablets

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode

Exclusion Criteria:

Patients previously treated with amisulpride
Patients have comorbidity which may interfere with the treatment or follow-up
Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse
Pregnant or lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436371

Locations

Hong Kong
Sanofi-Aventis
Hong Kong, Hong Kong

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Elaine Tang

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	L_9517
Study First Received:	February 15, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00436371 History of Changes
Health Authority:	Hong Kong: Department of Health

Study placed in the following topic categories:

Schizophrenia
Neurotransmitter Agents
Dopamine
Tranquilizing Agents
Mental Disorders
Sultopride

Psychotropic Drugs
Central Nervous System Depressants
Dopamine Agents
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Sultopride
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Schizophrenia
Mental Disorders
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009