Use of Omega-3 Fatty Acids for Perinatal Depression
|ClinicalTrials.gov Identifier: NCT00402389|
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : March 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression Depression, Postpartum||Drug: Omega-3 Fatty Acids (EPA plus DHA) Behavioral: Supportive psychotherapy Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Randomized Controlled Trial of Omega-3 Fatty Acids for Perinatal Depression|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
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.
- Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more [ Time Frame: Measured at Week 8 ]
- Reduction of EPDS score to less than or equal to 9 [ Time Frame: Measured at Week 8 ]
- CGI change score achievement of "very much improved" or "much improved" [ Time Frame: Measured at Week 8 ]
- Significant reductions in outcome measures of functional status and reduction of SIGH-ADS score of 50% [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402389
|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|