Status:
COMPLETED
Amisulpride in Schizophrenic Patients
Lead Sponsor:
Sanofi
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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- Current or recently withdrawn from drug abuse or alcoholism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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00331981
Start Date
February 1 2004
Last Update
April 10 2008
Active Locations (1)
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1
Sanofi-Aventis
Seoul, South Korea