Use of Omega-3 Fatty Acids for Perinatal Depression
Primary Purpose
Depression, Depression, Postpartum
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acids (EPA plus DHA)
Supportive psychotherapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Perinatal Depression, Postpartum Depression, Omega-3 Fatty Acids, Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), Pregnancy, Psychotherapy
Eligibility 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)
Sites / Locations
- Women's Mental Health Program; University of Arizona; Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Participants assigned to take omega-3 fatty acids
Participants assigned to take placebo
Outcomes
Primary Outcome Measures
Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more
Reduction of EPDS score to less than or equal to 9
CGI change score achievement of "very much improved" or "much improved"
Secondary Outcome Measures
Significant reductions in outcome measures of functional status and reduction of SIGH-ADS score of 50%
Changes in the level of omega-3 fatty acid composition of red blood cell membranes
Full Information
NCT ID
NCT00402389
First Posted
November 20, 2006
Last Updated
March 27, 2013
Sponsor
University of Arizona
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00402389
Brief Title
Use of Omega-3 Fatty Acids for Perinatal Depression
Official Title
Randomized Controlled Trial of Omega-3 Fatty Acids for Perinatal Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depression, Postpartum
Keywords
Perinatal Depression, Postpartum Depression, Omega-3 Fatty Acids, Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), Pregnancy, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants assigned to take omega-3 fatty acids
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants assigned to take placebo
Intervention Type
Drug
Intervention Name(s)
Omega-3 Fatty Acids (EPA plus DHA)
Intervention Description
Four capsules will be taken daily for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Supportive psychotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Four capsules will be taken daily for 8 weeks.
Primary Outcome Measure Information:
Title
Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more
Time Frame
Measured at Week 8
Title
Reduction of EPDS score to less than or equal to 9
Time Frame
Measured at Week 8
Title
CGI change score achievement of "very much improved" or "much improved"
Time Frame
Measured at Week 8
Secondary Outcome Measure Information:
Title
Significant reductions in outcome measures of functional status and reduction of SIGH-ADS score of 50%
Time Frame
Measured at Week 8
Title
Changes in the level of omega-3 fatty acid composition of red blood cell membranes
Time Frame
Measured at Weeks 1 and 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene P. Freeman, MD
Organizational Affiliation
University of Arizona; Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Mental Health Program; University of Arizona; Department of Psychiatry
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16390366
Citation
Freeman MP, Hibbeln JR, Wisner KL, Brumbach BH, Watchman M, Gelenberg AJ. Randomized dose-ranging pilot trial of omega-3 fatty acids for postpartum depression. Acta Psychiatr Scand. 2006 Jan;113(1):31-5. doi: 10.1111/j.1600-0447.2005.00660.x.
Results Reference
result
Learn more about this trial
Use of Omega-3 Fatty Acids for Perinatal Depression
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