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Amisulpride in Schizophrenic Acute Phase Patients

NCT ID: NCT00436371

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Amisulpride 400-800mg per day on a twice-a-day regimen

Group Type EXPERIMENTAL

Amisulpride

Intervention Type DRUG

Oral tablets

Interventions

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Amisulpride

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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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 3 months) withdrawn from drug or alcohol abuse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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Elaine Tang

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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L_9517

Identifier Type: -

Identifier Source: org_study_id