Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia

NCT00114595 | Completed Phase 4

• 3 other identifiers: 2002/M04402T-140N2/190802
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyskinesia; Schizophrenia

Keywords

eicosapentaenoic acid; tardive dyskinesia; omega-3; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change in Extrapyramidal Symptom Rating Scale (ESRS) dyskinesia score from baseline to week 12.

Secondary Outcomes (5)

• 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

Interventions

eicosapentaenoic acid DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Significant neurological disorder other than TD
• Substance abuse
• Significant other medical illness
• Psychiatric disorder not stabilised
• Patients currently receiving clozapine
• Pregnancy or lactation

Sponsors & Collaborators

• University of Stellenbosch: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Department of Psychiatry, Department of Health sciences, University of Stellenbosch

Cape Town, Western Cape, 7500, South Africa

Location

MeSH Terms

Conditions

Dyskinesias; Schizophrenia; Tardive Dyskinesia

Interventions

Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesia, Drug-Induced

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Robin Emsley, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2005
• First Posted: June 16, 2005
• Study Start: April 1, 2003
• Study Completion: March 1, 2005
• Last Updated: June 24, 2005

Record last verified: 2005-06

Locations

ZA (1)