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

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.

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 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.

Exclusion criteria

• 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.