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Amisulpride in Schizophrenic Patients
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00331981
  Purpose

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

Condition Intervention Phase
Schizophrenia
Drug: Amisulpride
Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Amisulpride Sultopride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • PANSS scores [ Time Frame: at every visit ]

Estimated Enrollment: 138
Study Start Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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  • Current or recently withdrawn from drug abuse or alcoholism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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331981

Locations
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Won Sik Lee, MD, PhD Sanofi-Aventis
  More Information

clinicalstudyresults.org  This link exits the ClinicalTrials.gov site

Study ID Numbers: L_8968
Study First Received: May 30, 2006
Last Updated: April 8, 2008
ClinicalTrials.gov Identifier: NCT00331981  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Sultopride
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009