Omega-3 for Peri- and Postmenopausal Depression

NCT00825994 | Completed Results

• 1 other identifier: 2008-P-001313
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 that an eight-week trial with omega-3 fatty acids promotes significant improvement in depression symptoms in peri- and postmenopausal women.

Conditions

Depression

Keywords

menopause; perimenopause; postmenopause; depression; mood; sleep; hot flashes

Outcome Measures

Primary Outcomes (1)

• Change in MADRS Score

  The instrument used to measure mood at each visit was the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).

  8 weeks

Secondary Outcomes (1)

• Change in Hot Flash Daily Interference Scale (HFRDIS)

  8 weeks

Study Arms (1)

Omega-3

EXPERIMENTAL

omega-3 fatty acids, 2grams qd \[every day\] (2 x 1 gram tablets), PO \[by mouth\]

Drug: Omega-3 Fatty Acids

Interventions

Omega-3 Fatty Acids DRUG

2 g omega-3 fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), PO \[by mouth\], qd \[every day\]

Also known as: Lovaza

Omega-3

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• MGH Center for Women's Mental Health Research Program

MeSH Terms

Conditions

Depression; Hot Flashes

Interventions

Fatty Acids, Omega-3; Omacor

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Marlene Freeman, MD
• Organization: Massachusetts General Hospital

mfreeman@partners.org

617-643-6403

Study Officials

• Marlene Freeman, MD

  Massachusetts General Hospital Perinatal and Reproductive Psychiatry Program

  PRINCIPAL INVESTIGATOR

• Lee S Cohen, MD

  Massachusetts General Hospital Perinatal and Reproductive Psychiatry Program

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Center for Women's Mental Health

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: January 21, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 21, 2014
• Results First Posted: August 21, 2014

Record last verified: 2014-08

Locations

US (1)