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OpenTrials
Completed

NCT Number: NCT00331981

Amisulpride in Schizophrenic Patients

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Current or recently withdrawn from drug abuse or alcoholism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.

Treatment and study plan

Amisulpride

Drug

Primary outcomes

  1. PANSS scores

    Time frame: at every visit

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients

Important dates

Study start
2004
First posted
May 31, 2006
Registry last updated
Apr 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.