The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)
NCT ID: NCT02166424
Last Updated: 2017-12-21
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
PHASE3
108 participants
INTERVENTIONAL
2014-06-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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
olive oil
2880mg olive oil daily
Olive oil
Interventions
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Omega-3 polyunsaturated fatty acids
Olive oil
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 take assessments 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. Serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
3. difficult to expect a normal birth (ex: fetal malformation etc.)
4. having a history of bleeding disorder such as von Willebrand's Disease
5. regular treatment with aspirin or warfarin within the last 3 months
6. a smoking habit of ≥40 cigarettes per day
7. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
8. a habit of eating fish as a main dish ≥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
National Center for Child Health and Development
UNKNOWN
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 Chuo Women's Hospital
Toda, Saitama, Japan
National Center for Child Health and Development
Setagaya City, Tokyo, Japan
Tokyo Medical University
Shinjyuku-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, Tachibana Y, Ito H, Isaka K, Hashimoto K, Hamazaki T, Matsuoka YJ. The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Sep 15;16(1):321. doi: 10.1186/s12888-016-1031-2.
Other Identifiers
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SYNCHRO-RCT
Identifier Type: -
Identifier Source: org_study_id