The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)

Study Overview
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Brief Summary
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The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

Detailed Description
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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.)

Official Title
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The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)

Conditions
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Pregnancy, Depression

Intervention / Treatment
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* Dietary Supplement: Omega-3 polyunsaturated fatty acids
* Dietary Supplement: Olive oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3 polyunsaturated fatty acids<br>1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily | Dietary Supplement: Omega-3 polyunsaturated fatty acids<br> <br> * Other names: 1200mg EPA and 600mg DHA daily;|
| Placebo Comparator: olive oil<br>2880mg olive oil daily | Dietary Supplement: Olive oil<br> <br> * Other names: 2880mg olive oil daily;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total score of the Hamilton Rating Scale for Depression (HAMD) |  | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Depression, omega-3 fatty acids