The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- total score of the Hamilton Rating Scale for Depression (HAMD)
研究概览
简要总结
The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
详细描述
Maternal depression can have a significant harmful influence on both mothers and children. Considering the possibility of adverse effects of antidepressants and previous meta-analyses showing the positive effects of omega-3 polyunsaturated fatty acids (PUFAs) supplementation in reducing depressive symptoms, omega-3 PUFAs may provide a safe strategy. The investigators evaluate efficacy and safety of omega-3 PUFAs for pregnant women with depressive symptoms. (Participants who skipped taking supplements for more than 7 days will be excluded from a per protocol analysis.)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women aged 20 years or older
- •between 12-24 weeks gestation
- •a Japanese conversational ability in Japan site or a Mandarin conversational ability in Taiwan site to understand the scope of the present trial and to provide written consent for study participation
- •planned to take assessments after childbirth
- •an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
- •to have good physical health judged by obstetricians.
排除标准
- •history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
- •Serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
- •difficult to expect a normal birth (ex: fetal malformation etc.)
- •having a history of bleeding disorder such as von Willebrand's Disease
- •regular treatment with aspirin or warfarin within the last 3 months
- •a smoking habit of ≥40 cigarettes per day
- •regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
- •a habit of eating fish as a main dish ≥4 times per week.
研究组 & 干预措施
Omega-3 polyunsaturated fatty acids
1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
干预措施: Omega-3 polyunsaturated fatty acids (Dietary Supplement)
olive oil
2880mg olive oil daily
干预措施: Olive oil (Dietary Supplement)
结局指标
主要结局
total score of the Hamilton Rating Scale for Depression (HAMD)
时间窗: Twelve weeks
次要结局
- total score of HAMD(4-6 weeks after childbirth)
- major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)(Twelve weeks, 4-6 weeks after childbirth)
- total scores on the Edinburgh Postnatal Depression Scale (EPDS)(Twelve weeks, 4-6 weeks after childbirth)
- total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)(Twelve weeks, 4-6 weeks after childbirth)
- omega-3 fatty acids concentrations in erythrocytes(Tweve weeks, 4-6 weeks after childbirth)
- brain-derived neurotrophic factor (BDNF) in serum(Twelve weeks, 4-6 weeks after childbirth)
- estrogen in plasma(twelve weeks, 4-6 weeks after childbirth)
- oxytocin in plasma(twelve weeks, 4-6 weeks after childbirth)
- progesterone in plasma(twelve weeks, 4-6 weeks after childbirth)
- human chorionic gonadotropin (hCG) in plasma(twelve weeks, 4-6 weeks after childbirth)
- phospholipase A2 in plasma(twelve weeks, 4-6 weeks after childbirth)
研究者
Daisuke Nishi
Assistant Professor
Tokyo Medical University