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 IV

Genetics Home Reference related topics:   Neurologic Diseases  

MedlinePlus related topics:   Schizophrenia  

ChemIDplus related topics:   Eicosapentaenoic acid  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114595

Locations
South Africa, Western Cape
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    
South Africa, Western Cape
Department of Psychiatry, Department of Health sciences, University of Stellenbosch    
      Cape Town, Western Cape, South Africa, 7500
University of Stellenbosch
Stanley Medical Research Institute
Principal Investigator:     Robin Emsley, MD    
  More Information

Study ID Numbers:   2002/M044, 02T-140, N2/190802
First Received:   June 15, 2005
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00114595
Health Authority:   South Africa: Medicines Control Council

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

Study placed in the following topic categories:
Schizophrenia
Signs and Symptoms
Mental Disorders
Movement Disorders
Neurologic Manifestations
Central Nervous System Diseases
Psychotic Disorders
Dyskinesias
Tardive dyskinesia
Schizophrenia and Disorders with Psychotic Features
Oral facial dyskinesia

Additional relevant MeSH terms:
Nervous System Diseases

Source: National Library of Medicine (NLM) July 08, 2008

  


 
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