NCT00436371

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
Last Updated

September 5, 2008

Status Verified

September 1, 2008

Enrollment Period

1.5 years

First QC Date

February 15, 2007

Last Update Submit

September 4, 2008

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    all across the study

Secondary Outcomes (4)

  • 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

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Amisulpride

Interventions

AmisulprideDRUG

Oral tablets

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode

You may not qualify if:

  • 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 3 months) withdrawn from drug or alcohol abuse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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Elaine Tang

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 19, 2007

Study Start

May 1, 2005

Primary Completion

November 1, 2006

Last Updated

September 5, 2008

Record last verified: 2008-09

Locations

HK(1)