跳至主要内容
临床试验/NCT00402389
NCT00402389已完成2 期

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

University of Arizona1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

1

Experimental

Participants assigned to take omega-3 fatty acids

干预措施: Omega-3 Fatty Acids (EPA plus DHA) (Drug)

1

Experimental

Participants assigned to take omega-3 fatty acids

干预措施: Supportive psychotherapy (Behavioral)

2

Placebo Comparator

Participants assigned to take placebo

干预措施: Supportive psychotherapy (Behavioral)

2

Placebo Comparator

Participants assigned to take placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Reduction of initial Edinburgh Postnatal Depression Scale (EPDS) score by 50% or more

时间窗: Measured at Week 8

Reduction of EPDS score to less than or equal to 9

时间窗: Measured at Week 8

CGI change score achievement of "very much improved" or "much improved"

时间窗: Measured at Week 8

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验