Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response
Status:
Withdrawn
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
This study will be a randomized controlled trial set in an outpatient clinic, involving
patients with major depressive disorder, who will be treated with antidepressant therapy,
which will be individually agreed upon by the subject and his or her physician. Patients will
be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid
(EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects
will complete a brief dietary and exercise habits survey at the beginning of the trial to
take into account lifestyle factors that may be significant in symptom resolution. Their
progress will be monitored over a period of twelve weeks, with standardized rating scales
completed by subjects and treating physicians. At the end of the study, scores will be
compared between groups to look for differences in timing and degree of symptom improvement
to analyze whether improvement occurred faster in the group receiving essential fatty acids
(EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of
antidepressant therapy with omega-3 fatty acids will decrease the lag period between the
start of therapy and the time of clinically significant symptom improvement. A secondary
hypothesis is that the results of this study will be consistent with numerous previous
studies showing improvement in symptom control in major depressive disorder when
antidepressants are supplemented with omega-3 fatty acids.