Amisulpride in Schizophrenic Acute Phase Patients (ASAP)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00436371
First received: February 15, 2007
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

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


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: The Use of Amisulpride in Schizophrenic Acute Phase Patients.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
Experimental: 1
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 3 months) withdrawn from drug or alcohol abuse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
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: NCT00436371

Locations
Hong Kong
Sanofi-Aventis
Hong Kong, Hong Kong
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Elaine Tang Sanofi
  More Information

No publications provided

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

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 18, 2014