Use of Omega-3 Fatty Acids for Perinatal Depression

March 27, 2013 updated by: University of Arizona

Randomized Controlled Trial of Omega-3 Fatty Acids for Perinatal Depression

This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is the chief cause of disease-associated disability in women. Because of the highs and lows during pregnancy through the first year of motherhood, expectant and new mothers are particularly prone to depression. Approximately 10% to 15% of women experience perinatal depression, which includes depression during pregnancy and/or postpartum depression. Signs of perinatal depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in the infant or family activities; excessive irritability and restlessness; thoughts of hurting self or infant; inability to concentrate; and lack of enjoyment in previously enjoyed activities. Depression occurring during pregnancy and postpartum can have a negative impact on the development and health of the baby. Additionally, maternal stress in humans is associated with lower birth weights and lower gestational ages at birth. Currently, there is a lack of knowledge on the use of antidepressants during pregnancy and postpartum, making this a significant health issue. Earlier studies have suggested that a depletion of omega-3 fatty acids during pregnancy might be the cause of depression and mood disorders in pregnant women. This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.

Participation in this double-blind study will last about 9 weeks. All participants will attend an initial screening visit and subsequent study visits, which will occur bi-weekly throughout the treatment phase. During these visits, participants will be asked questions about their medical and substance use history, demographic information, and eating behaviors. Participants will also complete questionnaires and interviews that will be used to assess their mental status, depression levels, marital/partner satisfaction levels, social/functional abilities, and overall mood levels. After the initial screening visit, eligible participants will be randomly assigned to receive either omega-3 fatty acids or placebo capsules. Participants in each group will be required to take four capsules on a daily basis for 8 weeks. During this treatment phase, all participants will also attend six weekly 30-minute supportive psychotherapy sessions. Blood samples for omega-3 fatty acid analysis will be taken on the first and last visits.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Women's Mental Health Program; University of Arizona; Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who are pregnant (12 to 32 weeks gestation) or postpartum
  • Meets criteria for a major depressive episode
  • Scores a minimum of 9 on the Edinburgh Postnatal Depression scale
  • Must be able to be treated on an outpatient basis

Exclusion Criteria:

  • Known intolerance or allergy to omega-3 fatty acid or fish oil
  • Presently taking antidepressant medication
  • Currently using heparin or warfarin (compounds used to prevent blood from clotting)
  • Presence of psychotic symptoms
  • History of mania (abnormally elevated mood state) or hypomania (same as mania but occurs at a much lesser degree)
  • Active suicidal ideation (desire to commit suicide)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Participants assigned to take omega-3 fatty acids
Drug: Omega-3 Fatty Acids (EPA plus DHA)
Four capsules will be taken daily for 8 weeks.
Behavioral: Supportive psychotherapy
Supportive psychotherapy will provide education to increase understanding of the condition, guidance on how to cope with depression, and methods on how to improve self-esteem.
PLACEBO_COMPARATOR: 2
Participants assigned to take placebo
Behavioral: Supportive psychotherapy
Supportive psychotherapy will provide education to increase understanding of the condition, guidance on how to cope with depression, and methods on how to improve self-esteem.
Drug: Placebo
Four capsules will be taken daily for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more
Time Frame: Measured at Week 8
Measured at Week 8
Reduction of EPDS score to less than or equal to 9
Time Frame: Measured at Week 8
Measured at Week 8
CGI change score achievement of "very much improved" or "much improved"
Time Frame: Measured at Week 8
Measured at Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Significant reductions in outcome measures of functional status and reduction of SIGH-ADS score of 50%
Time Frame: Measured at Week 8
Measured at Week 8
Changes in the level of omega-3 fatty acid composition of red blood cell membranes
Time Frame: Measured at Weeks 1 and 8
Measured at Weeks 1 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Marlene P. Freeman, MD, University of Arizona; Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

January 1, 2006

Study Completion (ACTUAL)

January 1, 2006

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (ESTIMATE)

November 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23MH066265 (NIH)
  • DATR AK-TNAI2 (Other Grant/Funding Number: Special grant NIMH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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