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
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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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2013-10-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Omega-3 polyunsaturated fatty acids
1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
Omega-3 polyunsaturated fatty acids
Interventions
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Omega-3 polyunsaturated fatty acids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
FEMALE
No
Sponsors
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China Medical University, Taiwan
OTHER
Japan Society for the Promotion of Science (JSPS)
UNKNOWN
University of Toyama
OTHER
Chiba University
OTHER
Tokyo Medical University
OTHER
Responsible Party
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Daisuke Nishi
Assistant Professor
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
Tokyo Medical University
Shinjuku-ku, Tokyo, Japan
China Medical University
Taichung, , Taiwan
Countries
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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.
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.
Other Identifiers
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SYNCHRO-Open
Identifier Type: -
Identifier Source: org_study_id
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