Amisulpride in Schizophrenic Patients

Phase 4

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00331981
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-08
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• 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

Exclusion Criteria

• 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• Current or recently withdrawn from drug abuse or alcoholism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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PANSS scores	at every visit

Trial Locations

Locations (1)

Sanofi-Aventis; 🇰🇷 Seoul, Korea, Republic of