UMIN-CTR Clinical Trial

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

depressive symptoms

Classification by specialty

Obstetrics and Gynecology

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Tokyo Medical University

Institute

Department

Personal name

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

Co-sponsor

China Medical University, Taiwan
University of Toyama
Chiba University
National Center for Child Health and Development

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2015

Year

06

Month

22

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024529/

Publication of results

Published

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

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 related information

Registered date

2015

Year

06

Month

19

Day

Last modified on

2018

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020425