Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Stellenbosch
• Collaborator: Stanley Medical Research Institute

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