Use of Omega-3 Fatty Acids for Perinatal Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00402389
First received: November 20, 2006
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Depression
Depression, Postpartum
Drug: Omega-3 Fatty Acids (EPA plus DHA)
Behavioral: Supportive psychotherapy
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Omega-3 Fatty Acids for Perinatal Depression

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Reduction of EPDS score to less than or equal to 9 [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • CGI change score achievement of "very much improved" or "much improved" [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant reductions in outcome measures of functional status and reduction of SIGH-ADS score of 50% [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Changes in the level of omega-3 fatty acid composition of red blood cell membranes [ Time Frame: Measured at Weeks 1 and 8 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402389

Locations
United States, Arizona
Women's Mental Health Program; University of Arizona; Department of Psychiatry
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Marlene P. Freeman, MD University of Arizona; Department of Psychiatry
  More Information

Publications:
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00402389     History of Changes
Other Study ID Numbers: K23 MH66265, K23MH066265, DATR AK-TNAI2
Study First Received: November 20, 2006
Last Updated: March 27, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Arizona:
Perinatal Depression
Postpartum Depression
Omega-3 Fatty Acids
Eicosapentaenoic Acid (EPA)
Docosahexaenoic Acid (DHA)
Pregnancy
Psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014