NCT00331981

Brief Summary

Primary purpose:

  • To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients
  • To find out how safe is long term treatment with amisulpride in schizophrenic patients Secondary purpose:
  • To find out how effective is long term treatment with amisulpride on the quality of life in schizophrenic patients
  • To find out how effective is long term treatment with amisulpride on the cognitive function in schizophrenic patients

Trial Health

80
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 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

February 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

First QC Date

May 30, 2006

Last Update Submit

April 8, 2008

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • PANSS scores

    at every visit

Interventions

AmisulprideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV
  • Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence

You may not qualify if:

  • Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder)
  • Patients hypersensitive to the active ingredient or to other ingredients of the study drug
  • Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer
  • Pheochromocytoma or Parkinson's disease
  • Pregnancy or breast feeding
  • Current or recently withdrawn from drug abuse or alcoholism
  • Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or that will affect the metabolism or effects of the trial medication
  • Patients with previous histories and clinical improvement was not seen in spite of treatment with 2 anti-psychotics for over 8 weeks
  • Slow heart rate of \<55bpm, low blood potassium level, congenital prolongation of the QT interval
  • Current treatment with a drug likely to cause markedly slow heart rate(\<55bpm), low blood potassium level, slowing of intercardiac condition or prolongation of the QT interval
  • 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

Seoul, South Korea

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

  • Won Sik Lee, MD, PhD

    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

May 30, 2006

First Posted

May 31, 2006

Study Start

February 1, 2004

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

KR(1)