The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO): Open Trial

NCT ID: NCT01948596

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-05-31

Brief Summary

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The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

Detailed Description

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Maternal depression can have a significant harmful influence on both mothers and children. Considering the possibility of adverse effects of antidepressants and previous meta-analyses showing the positive effects of omega-3 polyunsaturated fatty acids (PUFAs) supplementation in reducing depressive symptoms, omega-3 PUFAs may provide a safe strategy. The investigators evaluate efficacy and safety of omega-3 PUFAs for pregnant women with depressive symptoms.

Conditions

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Pregnancy Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omega-3 polyunsaturated fatty acids

1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily

Group Type EXPERIMENTAL

Omega-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omega-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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1200mg EPA and 600mg DHA daily

Eligibility Criteria

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Inclusion Criteria

1. pregnant women aged 20 years or older
2. between 12-24 weeks gestation
3. a Japanese conversational ability in Japan site or a Mandarin conversational ability in Taiwan site to understand the scope of the present trial and to provide written consent for study participation
4. planned to return to the hospital for checkup at 4-6 weeks after childbirth
5. an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
6. to have good physical health judged by obstetricians.

Exclusion Criteria

1. history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
2. the item of EPDS concerning suicide ideation is 2 or more
3. other serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
4. difficult to expect a normal birth (ex: fetal malformation etc.)
5. having a history of bleeding disorder such as von Willebrand's Disease
6. regular treatment with aspirin or warfarin within the last 3 months
7. a smoking habit of ≥40 cigarettes per day
8. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
9. a habit of eating fish ≥4 times per week.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, Taiwan

OTHER

Sponsor Role collaborator

Japan Society for the Promotion of Science (JSPS)

UNKNOWN

Sponsor Role collaborator

University of Toyama

OTHER

Sponsor Role collaborator

Chiba University

OTHER

Sponsor Role collaborator

Tokyo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Daisuke Nishi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daisuke Nishi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tokyo Medical University

Kuan-Pin Su, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical Univeristy

Locations

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Toda Maternity Hospital

Toda, Saitama, Japan

Site Status

Tokyo Medical University

Shinjuku-ku, Tokyo, Japan

Site Status

China Medical University

Taichung, , Taiwan

Site Status

Countries

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Japan Taiwan

References

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Nishi D, Su KP, Usuda K, Chiang YJ, Guu TW, Hamazaki K, Nakaya N, Sone T, Sano Y, Ito H, Isaka K, Hashimoto K, Hamazaki T, Matsuoka YJ. Omega-3 fatty acid supplementation for expectant mothers with depressive symptoms in Japan and Taiwan: An open-label trial. Psychiatry Clin Neurosci. 2016 Jun;70(6):253-4. doi: 10.1111/pcn.12388. Epub 2016 May 6. No abstract available.

Reference Type RESULT
PMID: 27004997 (View on PubMed)

Nishi D, Su KP, Usuda K, Chang JP, Chiang YJ, Guu TW, Hamazaki K, Nakaya N, Sone T, Hashimoto K, Hamazaki T, Matsuoka YJ. Differences between Japan and Taiwan in the treatment of pregnant women with depressive symptoms by omega-3 fatty acids: An open-label pilot study. Nutr Neurosci. 2019 Jan;22(1):63-71. doi: 10.1080/1028415X.2017.1354540. Epub 2017 Jul 28.

Reference Type DERIVED
PMID: 28752805 (View on PubMed)

Other Identifiers

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SYNCHRO-Open

Identifier Type: -

Identifier Source: org_study_id

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