- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00331981
Amisulpride in Schizophrenic Patients
April 8, 2008 updated by: Sanofi
Study of the Efficacy and Safety After Long-Term Treatment With 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
Study Overview
Study Type
Interventional
Enrollment
138
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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- Current or recently withdrawn from drug abuse or alcoholism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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PANSS scores
Time Frame: at every visit
|
at every visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Won Sik Lee, MD, PhD, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Registration Dates
First Submitted
May 30, 2006
First Submitted That Met QC Criteria
May 30, 2006
First Posted (ESTIMATE)
May 31, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
April 10, 2008
Last Update Submitted That Met QC Criteria
April 8, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Dopamine Agents
- Dopamine Antagonists
- Antidepressive Agents, Second-Generation
- Amisulpride
Other Study ID Numbers
- L_8968
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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