Status:
COMPLETED
Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia
Lead Sponsor:
University of Stellenbosch
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Dyskinesia
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Tardive dyskinesia is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. This study investigates whether the addition of the omega-3 fatty acid, ethyl-eicosa...
Detailed Description
Background: One of the major limitations of conventional antipsychotics is their high propensity to cause extrapyramidal symptoms (EPS). Tardive dyskinesia (TD) in particular causes problems, insofar...
Eligibility Criteria
Inclusion
- Male or female aged 18 to 60 yrs
- Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) criteria for TD.
- Meeting DSM-IV criteria for schizophrenia or schizo-affective disorder.
- CGI severity of TD score \>3.
- Patients from whom informed, written consent is obtained.
- Patients who have been on a fixed dose of antipsychotic medication for at least 6 weeks prior to trial entry.
Exclusion
- Significant neurological disorder other than TD
- Substance abuse
- Significant other medical illness
- Psychiatric disorder not stabilised
- Patients currently receiving clozapine
- Pregnancy or lactation
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00114595
Start Date
April 1 2003
End Date
March 1 2005
Last Update
June 24 2005
Active Locations (1)
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1
Department of Psychiatry, Department of Health sciences, University of Stellenbosch
Cape Town, Western Cape, South Africa, 7500