Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
138 participants
INTERVENTIONAL
2004-02-29
Brief Summary
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* 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
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Amisulpride
Eligibility Criteria
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Inclusion Criteria
* Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence
Exclusion Criteria
* 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* Current or recently withdrawn from drug abuse or alcoholism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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Principal Investigators
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Won Sik Lee, MD, PhD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Seoul, , South Korea
Countries
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Other Identifiers
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L_8968
Identifier Type: -
Identifier Source: org_study_id