title: The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.
abstract: Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive symptoms in Taiwan and Japan, to provide evidence available for Asia. The rationale and protocol of this trial are reported here.
  
  
  
  The Synchronized Trial on Expectant Mothers with Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) is a multicenter, double-blind, parallel group, randomized controlled trial. Participants will be randomized to either the omega-3 PUFAs arm (1,200 mg eicosapentaenoic acid and 600 mg docosahexaenoic acid daily) or placebo arm. Primary outcome is total score on the Hamilton Rating Scale for Depression (HAMD) at 12 weeks after the start of the intervention. We will randomize 56 participants to have 90 % power to detect a 4.7-point difference in mean HAMD scores with omega-3 PUFAs compared with placebo. Because seafood consumption varies across countries and this may have a major effect on the efficacy of omega-3 PUFA supplementation, 56 participants will be recruited at each site in Taiwan and Japan, for a total number of 112 participants. Secondary outcomes include depressive symptoms at 1 month after childbirth, diagnosis of major depressive disorder, changes in omega-3 PUFAs concentrations and levels of biomarkers at baseline and at 12 weeks' follow-up, and standard obstetric outcomes. Data analyses will be by intention to treat. The trial was started in June 2014 and is scheduled to end in February 2018.
  
  
  
  The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations.
  
  
  
  Clinicaltrials.gov: NCT02166424 . Registered 15 June 2014; University Hospital Medical Information Network (UMIN) Center: UMIN000017979. Registered 20 May 2015.
authors.affiliation: Department of Obstetrics and Gynecology, Tokyo Medical University, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan. d-nishi@umin.ac.jp.|National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8553, Japan. d-nishi@umin.ac.jp.|Department of Public Mental Health Policy, Graduate School of Medicine, The University of Tokyo, 4-1-1, Ogawahigashicyo, Kodaira, Tokyo, 187-8553, Japan. d-nishi@umin.ac.jp.
authors.forename: Daisuke
authors.identifier: 0000-0001-9349-3294
authors.initials: D
authors.lastname: Nishi
authors.affiliation: Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, No. 2, Yuh-Der Road, Taichung, 404, Taiwan. cobolsu@gmail.com.|Graduate Institute of Neural and Cognitive Sciences, College of Medicine, China Medical University, No.91, Hsueh-Shih Road, Taichung, 404, Taiwan. cobolsu@gmail.com.
authors.forename: Kuan-Pin
authors.initials: KP
authors.lastname: Su
authors.affiliation: Department of Obstetrics and Gynecology, Tokyo Medical University, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.|National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8553, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Usuda
authors.affiliation: Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, No. 2, Yuh-Der Road, Taichung, 404, Taiwan.
authors.forename: Yi-Ju Jill
authors.initials: YJ
authors.lastname: Chiang
authors.affiliation: Department of Psychiatry & Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, No. 2, Yuh-Der Road, Taichung, 404, Taiwan.
authors.forename: Tai-Wei
authors.initials: TW
authors.lastname: Guu
authors.affiliation: Department of Public Health, Faculty of Medicine, University of Toyama, 2630 Sugitani, Toyama, Toyama, 930-0194, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Hamazaki
authors.affiliation: Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8573, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Nakaya
authors.affiliation: Department of Rehabilitation, Faculty of Health Science, Tohoku Fukushi University, 6-149-1 Kunimigaoka, Aoba-ku, Sendai, Miyagi, 989-3201, Japan.
authors.forename: Toshimasa
authors.initials: T
authors.lastname: Sone
authors.affiliation: Toda Chuo Women's Hospital, 2-26-3 Kamitoda, Toda, Saitama, 335-0022, Japan.
authors.forename: Yo
authors.initials: Y
authors.lastname: Sano
authors.affiliation: Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine, National Center for Child Health and Development, 2-10-1 Ookura, Setagaya-ku, Tokyo, 157-8535, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Tachibana
authors.affiliation: Department of Obstetrics and Gynecology, Tokyo Medical University, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.
authors.forename: Hiroe
authors.initials: H
authors.lastname: Ito
authors.affiliation: Department of Obstetrics and Gynecology, Tokyo Medical University, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.
authors.forename: Keiich
authors.initials: K
authors.lastname: Isaka
authors.affiliation: Division of Clinical Neuroscience, Chiba University Center for Forensic Mental Health, 1-8-1 Inohana, Chiba, 260-8670, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Hashimoto
authors.affiliation: Department of Medicine, Toyama Jonan Onsen Daini Hospital, 1-13-6, Taromarunishimachi, Toyama, Toyama, 939-8271, Japan.
authors.forename: Tomohito
authors.initials: T
authors.lastname: Hamazaki
authors.affiliation: Department of Obstetrics and Gynecology, Tokyo Medical University, 6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.|Division of Health Care Research, Center for Public Health Sciences, National Cancer Center (YJM), 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
authors.forename: Yutaka J
authors.initials: YJ
authors.lastname: Matsuoka
mesh_terms: D000328:Adult; D002648:Child; D003866:Depressive Disorder / Q000523:psychology / Q000628:therapy*; D019587:Dietary Supplements; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D009035:Mothers / Q000523:psychology*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000523:psychology; D012107:Research Design; D013624:Taiwan; D016896:Treatment Outcome
chemical_list: D015525:Fatty Acids, Omega-3
keywords: Depression; Eicosapentaenoic acid; Omega-3 polyunsaturated fatty acids; Pregnancy; Prevention