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Amisulpride in Schizophrenic Acute Phase Patients (ASAP)

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

Secondary Outcome Measures:
  • Clinical Global Impressions [ Time Frame: All accross the study ]
  • Patient compliance [ Time Frame: all across the study ]
  • Percentage of patient completing treatment [ Time Frame: all across the study ]
  • Changes in body weight [ Time Frame: At baseline and day 84 ]

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 3 months) withdrawn from drug or alcohol abuse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 identifier: NCT00436371

Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Study Director: Elaine Tang Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00436371     History of Changes
Other Study ID Numbers: L_9517
Study First Received: February 15, 2007
Last Updated: September 4, 2008

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents processed this record on June 23, 2017