Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia

This study has been completed.
Sponsor:
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
  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
Endpoint Classification: Safety/Efficacy Study
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: South Africa: Medicines Control Council

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

Additional relevant MeSH terms:
Dyskinesias
Schizophrenia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014