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Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia

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ClinicalTrials.gov Identifier: NCT00114595
Recruitment Status : Completed
First Posted : June 16, 2005
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of Stellenbosch

Study Description
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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-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 or disease Intervention/treatment Phase
Dyskinesia Schizophrenia Drug: eicosapentaenoic acid Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2003
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in Extrapyramidal Symptom Rating Scale (ESRS) dyskinesia score from baseline to week 12.

Secondary Outcome Measures :
  1. Change in ESRS for parkinsonism, dystonia, akathisia, and total scores from baseline to week 12
  2. The proportion of subjects in each group who achieve a 30% reduction in ESRS total scores at week 12
  3. Time to remission (defined as a 30% reduction in ESRS total scores)
  4. The proportion of patients achieving a CGI Severity of TD score of < 3 at 12 weeks
  5. Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative and general psychopathology scores from baseline to week 12

Eligibility Criteria
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00114595     History of Changes
Other Study ID Numbers: 2002/M044
02T-140
N2/190802
First Posted: June 16, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2005

Keywords provided by University of Stellenbosch:
eicosapentaenoic acid
tardive dyskinesia
omega-3
schizophrenia

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Dyskinesia, Drug-Induced
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
 Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms