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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00402389 |
This study will evaluate the effectiveness of using omega-3 fatty acids to treat women with perinatal depression.
Condition | Intervention | Phase |
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Depression Depression, Postpartum |
Drug: Omega-3 Fatty Acids (EPA plus DHA) Behavioral: Supportive psychotherapy Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial of Omega-3 Fatty Acids for Perinatal Depression |
Enrollment: | 50 |
Study Start Date: | June 2004 |
Arms | Assigned Interventions |
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1: Experimental
Participants assigned to take omega-3 fatty acids
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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.
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2: Placebo Comparator
Participants assigned to take placebo
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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.
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Women's Mental Health Program; University of Arizona; Department of Psychiatry | |
Tucson, Arizona, United States, 85724 |
Principal Investigator: | Marlene P. Freeman, MD | University of Arizona; Department of Psychiatry |
Responsible Party: | University of Arizona ( Marlene P. Freeman, MD ) |
Study ID Numbers: | K23 MH66265, DATR AK-TNAI2 |
Study First Received: | November 20, 2006 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00402389 History of Changes |
Health Authority: | United States: Federal Government |
Perinatal Depression Postpartum Depression Omega-3 Fatty Acids Eicosapentaenoic Acid (EPA) |
Docosahexaenoic Acid (DHA) Pregnancy Psychotherapy |
Pregnancy Complications Depression Puerperal Disorders Depression, Postpartum |
Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |
Pregnancy Complications Depression Puerperal Disorders Depression, Postpartum |
Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |