Omega-3 for Peri- and Postmenopausal Depression

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jan 16, 2009

Keywords

ClinConnect Summary

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). Women are at a particularly high risk for depressive symptoms during the perimenopause, as demonstrated by epidemiological data that support a higher risk in perimenopause (15-18% prevalence rates) than premenopause (8-12%) (Bromberger et al., 2003). Women may be especially vulnerable to depressive symptoms during perimenopause due to declining levels of estrogen. Estrogen interacts with the neur...

Gender

FEMALE

Eligibility 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