Status:
COMPLETED
Omega-3 for Peri- and Postmenopausal Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Depression
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief 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...
Detailed Description
The perimenopause is commonly defined as a time of hormonal fluctuation that typically occurs in women 40-55 years of age with changes in menstrual patterns (Soares et al. 2001; Cohen et al. 2003). Wo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00825994
Start Date
November 1 2008
End Date
June 1 2009
Last Update
August 21 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114