Differences between Japan and Taiwan in the treatment of pregnant women with depressive symptoms by omega-3 fatty acids: An open-label pilot study

Abstract

Objectives: Although safe approaches for improving depression in pregnancy are required and the efficacy of omega-3 polyunsaturated fatty acids (PUFAs) has been suggested, the amount of supplemental omega-3 PUFAs has varied among previous studies and adequate amount might be different among countries. The aim of this pilot study is to explore the feasibility of using 1800 mg of omega-3 PUFAs supplementation for our future double-blind, placebo-control trial, and to clarify the clinical difference and the similarity between two sites of Japan and Taiwan.

Methods: Pregnant women between 12 and 24 weeks’ gestation with depressive symptoms were recruited. Participants were supplemented daily with omega-3 PUFAs capsules containing 1206 mg eicosapentaenoic acid and 609 mg docosahexaenoic acid for 12 weeks. The primary outcome was change in total score on the 17-item Hamilton Rating Scale for Depression (HAMD) at 12 weeks after supplementation.

Results: Eight pregnant women in Japan and five in Taiwan participated in the study. A substantial proportion of pregnant women reported high consumption of omega-3 supplements and dietary fish were excluded in Taiwan rather than in Japan sites. The decrease in HAMD score from baseline to 12 weeks after the start of the intervention was significantly larger in Japanese participants than in Taiwanese participants (Wilcoxon rank sum test; P = 0.045).

Discussion: The improvement of depressive symptoms was smaller at the Taiwan site than at the Japan site. Differences in psychopathology of recruited participants identified by self-rating scales might affect the degree of population heterogeneity and the treatment efficacy. A randomized-controlled trial is needed to confirm these findings.

Trial Registration: ClinicalTrials.gov Identifier: NCT01948596.

Keywords:

• Nutritional psychiatry
• Omega-3 fatty acids
• Eicosapentaenoic acid
• Depressive symptoms
• Pregnant women
• Prevention
• Clinical trial
• Cultural difference

Acknowledgements

Data and Safety Monitoring Board: Koichiro Watanabe, MD, PhD, Kyorin University, Tomohiro Nakao, MD, PhD, Kyushu University, and Katsumi Ikeshita, MD, PhD, ICHI Mental Clinic Nipponbashi.

We thank Miyuki Makino, Kasumi Araki, Natsuki Konno, and Yuuri Matsumura for participant recruitment and research coordination. We thank Yumiko Kamoshida for general research assistance, and Hiroko Hamatani and Shizuko Takebe for technical assistant in fatty acid analysis. We acknowledge the staff of Toda Chuo Women’s Hospital and Miss Grace Chien at the China Medical University, Taichung, Taiwan, for clinical data collection.

Disclaimer statements

Contributors DN, KPS and YJM conceived and designed the study, DN and KPS obtained funding, DN, KPS, K. Hamazaki, HI, KI and K. Hashimoto obtained ethics approval, DN, KPS, KU, YJC, TWG and YS collected the data, DN, NN and TS analyzed the data, all authors interpreted the data, DN and KPS wrote the article in whole, all other authors revised the article.

Funding This work was supported by Japan Society for the Promotion of Science under a Grant-in-Aid for Young Scientists (A) (25702043 to DN), National Center of Neurology and Psychiatry Japan under intramural Research Projects of NCNP (27-3 to DN), the Ministry of Science and Technology Taiwan (S44 to KPS) and China Medical University (CMU104-S1603 to KPS).

Conflicts of interest Dr Nishi has received research grants from the Japan Society for the Promotion of Science, the National Center of Neurology and Psychiatry Japan, 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 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; consultant fees from Polyene Project, Inc. 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.

Ethics approval None.

ORCID

Daisuke Nishi http://orcid.org/0000-0001-9349-3294

Kuan-Pin Su http://orcid.org/0000-0002-4501-2502

Jane Pei-Chen Chang http://orcid.org/0000-0001-5582-0928

Yutaka J. Matsuoka http://orcid.org/0000-0002-8690-8129