Amisulpride in Schizophrenic Patients
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00331981
First received: May 30, 2006
Last updated: April 8, 2008
Last verified: April 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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- Current or recently withdrawn from drug abuse or alcoholism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
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 May 16, 2013