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Awarded Trial: 02T-140
Grant ID
02T-140
Illness
Tardive Dyskinesia
Primary Drug/Intervention
Ethyl Eicosapentanoic Acid
Primary Dosage
1000 mg b.i.d.
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Emsley
Sample Size
84
Duration of Study Period for Each Subject
12 weeks + 40 weeks open-label extension
Outcome Measurements
Extrapyramidal Symptom Rating Scale, PANSS, CGI
Results
Eighty-four subjects were randomized, of whom 77 were included in the analysis. Both the EPA and placebo groups displayed significant baseline to endpoint improvements in Extrapyramidal Symptom Rating Scale dyskinesia scores, but there were no significant between-group differences (p=0.4). Response rates (>=30% improvement in TD symptoms) also did not different significantly between EPA-treated subjects (45%) and placebo-treated subjects (32%) (p=0.6).
Publication
Emsley R, Niehaus DJ, Koen L, Oosthuizen PP, Turner HJ, Carey P, van Rensburg SJ, Maritz JS, Murck H. The effects of eicosapentaenoic acid in tardive dyskinesia: a randomized, placebo-controlled trial. Schizophr Res. 2006 May;84(1):112-20. Epub 2006 Apr 24.
Link
http://www.ncbi.nlm.nih.gov/pubmed/16632329
PI Name
Robin Emsley
Degree
MD
Center
Department of Psychiatry
Institution
University of Stellenbosch
Address
P.O. Box 19063, Tygerberg
City or Town
Cape Town
State or Province
N/A
Zip or Postal Code
7505
Country
South Africa
Email Address
rae@sun.ac.za