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BMC Psychiatry
Published in: BMC Psychiatry 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Daisuke Nishi, Kuan-Pin Su, Kentaro Usuda, Yi-Ju Jill Chiang, Tai-Wei Guu, Kei Hamazaki, Naoki Nakaya, Toshimasa Sone, Yo Sano, Yoshiyuki Tachibana, Hiroe Ito, Keiich Isaka, Kenji Hashimoto, Tomohito Hamazaki, Yutaka J Matsuoka

Published in: BMC Psychiatry | Issue 1/2016

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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.
Appendix
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Metadata
Title
The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial
Authors
Daisuke Nishi
Kuan-Pin Su
Kentaro Usuda
Yi-Ju Jill Chiang
Tai-Wei Guu
Kei Hamazaki
Naoki Nakaya
Toshimasa Sone
Yo Sano
Yoshiyuki Tachibana
Hiroe Ito
Keiich Isaka
Kenji Hashimoto
Tomohito Hamazaki
Yutaka J Matsuoka
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2016
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-016-1031-2

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