Amisulpride in Schizophrenic Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amisulpride; Sulpiride; Sultopride

Criteria

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• Current or recently withdrawn from drug abuse or alcoholism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.