NCT07013981已完成不适用
The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)in Tokyo: Open Trial
National Science and Technology Council, Taiwan1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2013年1月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 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.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（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 to understand the scope of the present trial.
- •planned to return to the hospital for checkup at 4-6 weeks 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.
- •the item of EPDS concerning suicide ideation is 2 or more.
- •other 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 ≥4 times per week.
结局指标
主要结局
Total score of the Hamilton Rating Scale for Depression(HAMD)
时间窗: Twelve weeks
The Hamilton Rating Scale for Depression (HAMD) is a commonly used clinical tool for assessing the severity of depression. The most frequently used version, the HAMD-17, includes 17 items and has a total score range from 0 to 52. Higher scores indicate more severe depressive symptoms and thus a worse outcome, while lower scores suggest milder symptoms or improvement.
次要结局
- Total scores on the Edinburgh Postnatal Depression Scale(EPDS)(Twelve weeks, 4-6 weeks after childbirth)
- Brain-derived neurotrophic factor(BDNF)in serum(Twelve weeks, 4-6 weeks after childbirth)
- Total score of the Hamilton Rating Scale for Depression(HAMD)(4-6 weeks after childbirth)
- Total score of the Beck Depression Inventory II (BDI-II)(Twelve weeks, 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)
- Omega-3 fatty acids concentrations in erythrocytes(Twelve weeks, 4-6 weeks after childbirth)
- Estrogen in serum(Twelve weeks, 4-6 weeks after childbirth)
- Oxytocin in serum(Twelve weeks, 4-6 weeks after childbirth)
- Progesterone in serum(Twelve weeks, 4-6 weeks after childbirth)
- Human chorionic gonadotropin (hCG)in serum(Twelve weeks, 4-6 weeks after childbirth)
- Phospholipase A2 in plasma(twelve weeks, 4-6 weeks after childbirth)
研究者
Kuan-Pin
Professor
National Science and Technology Council, Taiwan
研究点 (1)
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