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Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia
This study has been completed.
Sponsor:
University of Stellenbosch
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of Stellenbosch
ClinicalTrials.gov Identifier:
NCT00114595
First received: June 15, 2005
Last updated: June 23, 2005
Last verified: June 2005
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Purpose
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-eicosapentaenoic acid (EPA) to usual treatment improves movement disorder in 84 schizophrenia subjects with established tardive dyskinesia. The initial double-blinded, randomised trial duration is 12 weeks, followed by further 46 weeks of open-label treatment.
| Condition | Intervention | Phase |
|---|---|---|
| Dyskinesia Schizophrenia | Drug: eicosapentaenoic acid | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomised, Parallel-Group Comparison of Ethyl-Eicosapentaenoic Acid (Ethyl-EPA) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
U.S. FDA Resources
Further study details as provided by University of Stellenbosch:
Primary Outcome Measures:
- Change in Extrapyramidal Symptom Rating Scale (ESRS) dyskinesia score from baseline to week 12.
Secondary Outcome Measures:
- Change in ESRS for parkinsonism, dystonia, akathisia, and total scores from baseline to week 12
- The proportion of subjects in each group who achieve a 30% reduction in ESRS total scores at week 12
- Time to remission (defined as a 30% reduction in ESRS total scores)
- The proportion of patients achieving a CGI Severity of TD score of < 3 at 12 weeks
- Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative and general psychopathology scores from baseline to week 12
| Estimated Enrollment: | 84 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | March 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- Significant neurological disorder other than TD
- Substance abuse
- Significant other medical illness
- Psychiatric disorder not stabilised
- Patients currently receiving clozapine
- Pregnancy or lactation
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00114595
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114595
Locations
| South Africa | |
| Department of Psychiatry, Department of Health sciences, University of Stellenbosch | |
| Cape Town, Western Cape, South Africa, 7500 | |
Sponsors and Collaborators
University of Stellenbosch
Stanley Medical Research Institute
Investigators
| Principal Investigator: | Robin Emsley, MD |
More Information
| ClinicalTrials.gov Identifier: | NCT00114595 History of Changes |
| Other Study ID Numbers: |
2002/M044 02T-140 N2/190802 |
| Study First Received: | June 15, 2005 |
| Last Updated: | June 23, 2005 |
Keywords provided by University of Stellenbosch:
|
eicosapentaenoic acid tardive dyskinesia omega-3 schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Dyskinesias Movement Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on July 21, 2017