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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017979
Receipt No. R000020425
Scientific Title The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs
Date of disclosure of the study information 2015/06/22
Last modified on 2018/12/20

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Basic information
Public title The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs
Acronym SYNCHRO
Scientific Title The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs
Scientific Title:Acronym SYNCHRO
Region
Japan Asia(except Japan)

Condition
Condition depressive symptoms
Classification by specialty
Obsterics and gynecology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes total score of the Hamilton Rating Scale for Depression (HAMD) [ Time Frame: Twelve weeks ]
Key secondary outcomes total score of HAMD at 4-6 weeks after childbirth
Major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI) at 12 weeks, at 4-6 weeks after childbirth
total scores on the Edinburgh Postnatal Depression Scale (EPDS) at 12 weeks, 4-6 weeks after childbirth
total score of the Beck Depression Inventory 2(BDI-2) at 12 weeks, 4-6 weeks after childbirth

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Dietary Supplement: Omega-3 polyunsaturated fatty acids
Other Name: 1200mg EPA and 600mg DHA daily
Interventions/Control_2 Dietary Supplement: Olive oil
Other Name: 2880mg olive oil daily
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key 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 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.
Key exclusion criteria 1. history and current suspicion of psychosis or bipolar 1 disorder or substance-related disorder or eating disorder or personality disorder
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 or more 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 or more per week.
Target sample size 112

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Nishi
Organization Tokyo Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111(5866)
Email d-nishi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Nishi
Organization National Center of Neurology and Psychiatry
Division name National Institute of Mental Health
Zip code
Address 4-1-1, Ogawahigashicho, Kodaira, Tokyo
TEL 042-341-2711
Homepage URL https://clinicaltrials.gov/ct2/show/NCT02166424?term=NCT02166424&rank=1
Email d-nishi@umin.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
National Center of Neurology and Psychiatry, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor China Medical University, Taiwan
University of Toyama
Chiba University
National Center for Child Health and Development
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02166424
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科大学病院(東京都)、戸田中央産院(埼玉県)、国立成育医療研究センター(東京都)、中国医薬大学(台湾)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 22 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024529/
Publication of results Published

Result
URL related to results and publications https://www.karger.com/Article/FullText/495296
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 15 Day
Last follow-up date
2017 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 19 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020425

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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