TY - JOUR
T1 - The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO)
T2 - Study protocol for a randomized controlled trial
AU - Nishi, Daisuke
AU - Su, Kuan Pin
AU - Usuda, Kentaro
AU - Chiang, Yi Ju Jill
AU - Guu, Tai Wei
AU - Hamazaki, Kei
AU - Nakaya, Naoki
AU - Sone, Toshimasa
AU - Sano, Yo
AU - Tachibana, Yoshiyuki
AU - Ito, Hiroe
AU - Isaka, Keiich
AU - Hashimoto, Kenji
AU - Hamazaki, Tomohito
AU - Matsuoka, Yutaka J.
N1 - Funding Information:
This work was supported by Grant-in-Aid for Young Scientists (A) from the Japan Society for the Promotion of Science (25702043) and Intramural Research Grant (27-3-2) for Neurological and Psychiatric Disorders of National Center of Neurology and Psychiatry, Japan (to DN) and from the Taiwan Ministry of Science and Technology and China Medical University (to KPS). The funding body peer reviewed proposal documents which included a digest version of this study protocol as part of the selection process. All of the supplements used in the study were supplied by Kentech Co, Ltd., Toyama, Japan, which had no role in the study design and conduct, in the collection, analysis and interpretation of the data, or in the preparation, review, and approval of the manuscript.
Funding Information:
Dr. Nishi has received research grants from the Japan Society for the Promotion of Science, the National Center of Neurology and Psychiatry Japan, the Ministry of Health, Labour and Welfare, and Japan Agency for Medical Research and Development, and a lecture fee from Otsuka Pharmaceutical Co., Ltd., and a manuscript fee from Sumitomo Dainippon Pharma Co., Ltd. Dr. Su has received research grants from the Taiwan Ministry of Science and Technology and China Medical University. Dr. Kei Hamazaki received research support from an Intramural Research Grant for Neurological and Psychiatric Disorders from the National Center of Neurology and Psychiatry and a grant from the Japan Society for the Promotion of Science; and scholarship donations from Otsuka Pharmaceutical Co., Ltd. Dr. Tomohito Hamazaki has received lecture fees from Takeda Pharmaceutical Co., Ltd. and travel expenses from Aker BioMarine. Dr. Matsuoka has received an Intramural Research Grant for Neurological and Psychiatric Disorders from the National Center of Neurology and Psychiatry Japan and a grant from Pfizer Health Research Foundation, as well as lecture fees from Ono Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Ltd., Suntory Wellness Ltd., DHA & EPA Association, and Otsuka Pharmaceutical Co., Ltd. No other authors report any financial disclosures.
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/9/15
Y1 - 2016/9/15
N2 - 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.
AB - 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.
KW - Depression
KW - Eicosapentaenoic acid
KW - Omega-3 polyunsaturated fatty acids
KW - Pregnancy
KW - Prevention
UR - http://www.scopus.com/inward/record.url?scp=84987752635&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84987752635&partnerID=8YFLogxK
U2 - 10.1186/s12888-016-1031-2
DO - 10.1186/s12888-016-1031-2
M3 - Article
C2 - 27630014
AN - SCOPUS:84987752635
VL - 16
JO - BMC Psychiatry
JF - BMC Psychiatry
SN - 1471-244X
IS - 1
M1 - 321
ER -