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Amisulpride in Schizophrenic Patients

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ClinicalTrials.gov Identifier: NCT00331981
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Amisulpride Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients
Study Start Date : February 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. PANSS scores [ Time Frame: at every visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331981


Locations
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Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Won Sik Lee, MD, PhD Sanofi
More Information
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ClinicalTrials.gov Identifier: NCT00331981    
Other Study ID Numbers: L_8968
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Amisulpride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents