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Amisulpride in Schizophrenic Acute Phase Patients (ASAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436371
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : September 5, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Amisulpride Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Amisulpride in Schizophrenic Acute Phase Patients.
Study Start Date : May 2005
Actual Primary Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Amisulpride

Arm Intervention/treatment
Experimental: 1
Amisulpride 400-800mg per day on a twice-a-day regimen
Drug: Amisulpride
Oral tablets

Primary Outcome Measures :
  1. Adverse events [ Time Frame: all across the study ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436371

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Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
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Study Director: Elaine Tang Sanofi
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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00436371    
Other Study ID Numbers: L_9517
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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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