Amisulpride in Schizophrenic Acute Phase Patients (ASAP)

The Use of Amisulpride in Schizophrenic Acute Phase Patients.

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Amisulpride

• Study Type: Interventional
• Enrollment: 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 3 months) withdrawn from drug or alcohol abuse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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events	all across the study

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Elaine Tang, Sanofi

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): November 1, 2006
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: February 15, 2007
• First Submitted That Met QC Criteria: February 15, 2007
• First Posted (Estimate): February 19, 2007

Study Record Updates

• Last Update Posted (Estimate): September 5, 2008
• Last Update Submitted That Met QC Criteria: September 4, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Dopamine Agents; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Amisulpride
• Other Study ID Numbers: L_9517

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No