Nishi 2015 (SYNCHRO).

Trial name or title	SYNCHRO
Methods	RCT (multi centre): NCT02166424
Participants	Recruitment target: 108 women. Inclusion criteria: ≥ 20 years; 12‐24 weeks' gestation, Japanese conversational ability in Japan site, Mandarin conversational ability in Taiwan site, willing to take assessments after childbirth, with EPDS 9 or more and in good physical health (judged by obstetricians). Exclusion criteria: history and current suspicion of psychosis or bipolar disorder or substance‐related disorder or eating disorder or personality disorder, serious phychiatric symptoms such as self‐harm behaviour or in need of rapid psychiatric treatment, difficult to expect a normal birth, having a history of bleeding disorder such as von Willebrand's Disease, regular treatment with Asprin 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, and a habit of eating fish as a main dish ≥ times per week. Setting: Japan and Taiwan.
Interventions	Intervention group Omega‐3 polyunsaturated fatty acids (1200 mg eicosapentaenoic acid EPA and 600 mg DHA daily). Control group Placebo (2880 mg olive oil daily).
Outcomes	Primary outcome: total score on HAMD (12 weeks). Other outcomes: total score on HAMD (4‐6 weeks after childbirth); MDD as determined by the depression module of MINI (4‐6 weeks after childbirth); total scores on EPDS (4‐6 weeks after childbirth); total score on BDI‐Ⅱ (4‐6 weeks after childbirth); omega‐3 fatty acids concentrations in erythrocytes (4‐6 weeks after childbirth); oestrogen in plasma (4‐6 weeks after childbirth); oxytocin in plasmal (4‐6 weeks after childbirth); progesterone in plasma (4‐6 weeks after childbirth), hCG in plasma (4‐6 weeks after childbirth), phospholipase A2 in plasma (4‐6 weeks after childbirth);gestational age (at childbirth); GDM (4‐6 weeks after childbirth); gestational hypertension or pre‐eclampsia (4‐6 weeks after childbirth); gestational hypertension or pre‐eclampsia (4‐6 weeks after childbirth); induced labour; blood loss at childbirth; caesarean section; operative vaginal birth; birthweight; Apgar score (at 1 minute and 5 minutes); NICU admission (4‐6 weeks after childbirth); and cholesterol (4‐6 weeks after childbirth).
Starting date	June 2014
Contact information	Daisuke Nishi, Assistant Professor, Tokyo Medical University. E‐mail: d‐nishi@umin.ac.jp
Notes	Funding and collaborators: Tokyo Medical University, China Medical University (Taiwan), University of Toyama, Chiba University, and National Center for Child Health and Development. A non‐randomised pilot for this study was registered as NCT01948596 (completed: Nishi 2016)