Omega-3 for Peri- and Postmenopausal Depression

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if an eight-week intervention with omega-3 fatty acids significantly reduces depressive symptoms in symptomatic peri- and postmenopausal women. We hypothesize that an eight-week trial with omega-3 fatty acids promotes significant improvement in depression symptoms in peri- and postmenopausal women.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Women age 40 and older in the peri- or postmenopausal period, as defined in Soules et al. 2001

• Meet criteria for Major Depressive Disorder on the MINI (Mini-International Neuropsychiatric Interview)

• Score of 18 or greater on MADRS (Montgomery-Asberg Depression Rating Scale) at screening visit

• Do not meet criteria for placebo response during placebo run-in phase; placebo response is defined as a > 50% decrease in MADRS from screening to end of placebo run-in phase

• Willing to receive treatment on an outpatient basis

• Presence of general good health

Exclusion Criteria:

• Currently pregnant, trying to conceive, or breastfeeding

• Treatment with an antidepressant medication currently or in the past 1 month

• Treatment with hormone replacement therapy currently or in the past 1 month

• Treatment with Omega-3 supplements currently or in the past 1 month

• Use of birth control pills currently or in the past 1 month

• Presence of suicidal ideation

• Meet criteria for current or within the past month for panic disorder, obsessive compulsive disorder (OCD), psychosis, mania or hypomania, as assessed by the MINI

• Diagnosis of treatment resistant Major Depressive Disorder, defined as patients who have been treated with two or more therapeutic courses of antidepressant medication without remission of symptoms for the current episode of depression, as assessed by the MINI

• Any medical condition that would make participation in the study unsafe, as determined by investigator

• Presence of a known allergy to fish or fish oil that would put participant at risk, as determined by a study investigator