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

Phase 3

Completed

• Conditions: Pregnancy; Depression
• Interventions: Dietary Supplement: Olive oil; Dietary Supplement: Omega-3 polyunsaturated fatty acids

• Registration Number: NCT02166424
• Lead Sponsor: Tokyo Medical University

Brief Summary

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

Detailed Description

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.)

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-15
• Study First Submitted QC: 2014-06-15
• Study First Posted: 2014-06-18
• Primary Completion: 2017-08
• Status Verified: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

1. pregnant women aged 20 years or older
2. between 12-24 weeks gestation
3. 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
4. planned to take assessments after childbirth
5. an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
6. to have good physical health judged by obstetricians.

Exclusion Criteria

1. history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
2. Serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
3. difficult to expect a normal birth (ex: fetal malformation etc.)
4. having a history of bleeding disorder such as von Willebrand's Disease
5. regular treatment with aspirin or warfarin within the last 3 months
6. a smoking habit of ≥40 cigarettes per day
7. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
8. a habit of eating fish as a main dish ≥4 times per week.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
olive oil	Olive oil	2880mg olive oil daily
Omega-3 polyunsaturated fatty acids	Omega-3 polyunsaturated fatty acids	1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily

Primary Outcome Measures

Name	Time	Method
total score of the Hamilton Rating Scale for Depression (HAMD)	Twelve weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

China Medical University; 🇨🇳 Taichung, Taiwan

Toda Chuo Women's Hospital; 🇯🇵 Toda, Saitama, Japan

National Center for Child Health and Development; 🇯🇵 Setagaya, Tokyo, Japan

Tokyo Medical University; 🇯🇵 Shinjyuku-ku, Tokyo, Japan