Amisulpride in Schizophrenic Patients

Sanofi

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Amisulpride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00331981

L_8968

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Current or recently withdrawn from drug abuse or alcoholism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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)