NCT00402389

Use of Omega-3 Fatty Acids for Perinatal Depression

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Depression, Postpartum

Interventions

Type	Name	Description
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.
DRUG	Placebo	Four capsules will be taken daily for 8 weeks.

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2006-11-22
• Last updated: 2013-03-29

Locations

1 site across 1 country: United States