Amisulpride in Schizophrenic Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00331981
First received: May 30, 2006
Last updated: April 8, 2008
Last verified: April 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

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  • Current or recently withdrawn from drug abuse or alcoholism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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Won Sik Lee, MD, PhD Sanofi
  More Information

No publications provided

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sultopride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014