Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Sep 15;16(1):321.
doi: 10.1186/s12888-016-1031-2.

The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial

Daisuke Nishi  1   2   3 , Kuan-Pin Su  4   5 , Kentaro Usuda  6   7 , Yi-Ju Jill Chiang  8 , Tai-Wei Guu  8 , Kei Hamazaki  9 , Naoki Nakaya  10 , Toshimasa Sone  11 , Yo Sano  12 , Yoshiyuki Tachibana  13 , Hiroe Ito  6 , Keiich Isaka  6 , Kenji Hashimoto  14 , Tomohito Hamazaki  15 , Yutaka J Matsuoka  6   16
Affiliations
Randomized Controlled Trial

The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial

Daisuke Nishi et al. BMC Psychiatry. .

Abstract

Background: 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.

Methods: 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.

Discussion: The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations.

Trial registration: Clinicaltrials.gov: NCT02166424 . Registered 15 June 2014; University Hospital Medical Information Network (UMIN) Center: UMIN000017979. Registered 20 May 2015.

Keywords: Depression; Eicosapentaenoic acid; Omega-3 polyunsaturated fatty acids; Pregnancy; Prevention.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flow diagram of the study. EPDS: Edinburgh Postnatal Depression Scale; MDD: major depressive disorders
See this image and copyright information in PMC

References

    1. Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004;103(4):698–709. doi: 10.1097/01.AOG.0000116689.75396.5f. - DOI - PubMed
    1. Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005;106(5 Pt 1):1071–1083. doi: 10.1097/01.AOG.0000183597.31630.db. - DOI - PubMed
    1. Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, Ramin S, Chaudron L, Lockwood C. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Gen Hosp Psychiatry. 2009;31(5):403–413. doi: 10.1016/j.genhosppsych.2009.04.003. - DOI - PMC - PubMed
    1. Davis EP, Glynn LM, Schetter CD, Hobel C, Chicz-Demet A, Sandman CA. Prenatal exposure to maternal depression and cortisol influences infant temperament. J Am Acad Child Adolesc Psychiatry. 2007;46(6):737–746. doi: 10.1097/chi.0b013e318047b775. - DOI - PubMed
    1. Leech SL, Larkby CA, Day R, Day NL. Predictors and correlates of high levels of depression and anxiety symptoms among children at age 10. J Am Acad Child Adolesc Psychiatry. 2006;45(2):223–230. doi: 10.1097/01.chi.0000184930.18552.4d. - DOI - PubMed

Publication types

Substances

Associated data