Double-blind, randomized, placebo-controlled trials of ethyl-eicosapentanoate in the treatment of bipolar depression and rapid cycling bipolar disorder.
BACKGROUND
The results of pilot trials suggest that omega-3 fatty acids may have efficacy in the treatment of mood symptoms in bipolar disorder.


METHODS
We conducted a 4-month, randomized, placebo-controlled, adjunctive trial of ethyl-eicosapentanoate (EPA) 6 g/day in the treatment of bipolar depression and rapid cycling bipolar disorder. Subjects were receiving mood-stabilizing medications at therapeutic doses or plasma concentrations. The measures of efficacy were early study discontinuation, changes from baseline in depressive symptoms (Inventory for Depressive Symptomology total score) and in manic symptoms (Young Mania Rating Scale total score), and manic exacerbations ("switches"). We also measured side effects and bleeding time, a biomarker of drug action.


RESULTS
Overall, there were no significant differences on any outcome measure between the EPA and placebo groups.


CONCLUSIONS
This study did not find overall evidence of efficacy for adjunctive treatment with EPA 6 g/day in outpatients with bipolar depression or rapid cycling bipolar disorder.
Keck
Paul E
PE
Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine and the Mental Health Care Line, Cincinnati, Ohio 45267-0559, USA. paul.keck@UC.edu
Mintz
Jim
J
McElroy
Susan L
SL
Freeman
Marlene P
MP
Suppes
Trisha
T
Frye
Mark A
MA
Altshuler
Lori L
LL
Kupka
Ralph
R
Nolen
Willem A
WA
Leverich
Gabriele S
GS
Denicoff
Kirk D
KD
Grunze
Heinz
H
Duan
Naihua
N
Post
Robert M
RM
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000145:classification* / Q000188:drug therapy*; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D000928:Antidepressive Agents; C035276:eicosapentaenoic acid ethyl ester; D015118:Eicosapentaenoic Acid