Use of Omega-3 Fatty Acids for Perinatal Depression

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

Detailed Description
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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.

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

Conditions
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Depression, Depression, Postpartum

Intervention / Treatment
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* Drug: Omega-3 Fatty Acids (EPA plus DHA)
* Behavioral: Supportive psychotherapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants assigned to take omega-3 fatty acids | Drug: Omega-3 Fatty Acids (EPA plus DHA)<br>* Four capsules will be taken daily for 8 weeks.<br>Behavioral: Supportive psychotherapy<br>* 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.<br>|
| Placebo Comparator: 2<br>Participants assigned to take placebo | Behavioral: Supportive psychotherapy<br>* 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.<br>Drug: Placebo<br>* Four capsules will be taken daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal Depression, Postpartum Depression, Omega-3 Fatty Acids, Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), Pregnancy, Psychotherapy