Back to resultsThe Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO): Open Trial
Primary Purpose
Pregnancy, Depression
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Omega-3 polyunsaturated fatty acids
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring pregnant women, depression, depressive symptoms, omega-3 fatty acids
Eligibility Criteria
Inclusion Criteria:
- pregnant women aged 20 years or older
- between 12-24 weeks gestation
- 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
- planned to return to the hospital for checkup at 4-6 weeks after childbirth
- an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
- to have good physical health judged by obstetricians.
Exclusion Criteria:
- history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
- the item of EPDS concerning suicide ideation is 2 or more
- other serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
- difficult to expect a normal birth (ex: fetal malformation etc.)
- having a history of bleeding disorder such as von Willebrand's Disease
- regular treatment with aspirin or warfarin within the last 3 months
- a smoking habit of ≥40 cigarettes per day
- regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
- a habit of eating fish ≥4 times per week.
Sites / Locations
- Toda Maternity Hospital
- Tokyo Medical University
- China Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omega-3 polyunsaturated fatty acids
Arm Description
1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
Outcomes
Primary Outcome Measures
total score of the Hamilton Rating Scale for Depression (HAMD)
Secondary Outcome Measures
total score of HAMD
total scores on the Edinburgh Postnatal Depression Scale (EPDS)
total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)
major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)
omega-3 fatty acids concentrations in erythrocytes
brain-derived neurotrophic factor (BDNF) in serum
IF-6 in plasma
oxytocin in plasma
TNF-alpha in plasma
IL-1 beta in plasma
phospholipase A2 in plasma
Full Information
NCT ID
NCT01948596
First Posted
September 12, 2013
Last Updated
April 19, 2016
Sponsor
Tokyo Medical University
Collaborators
China Medical University, Taiwan, Japan Society for the Promotion of Science (JSPS), University of Toyama, Chiba University
1. Study Identification
Unique Protocol Identification Number
NCT01948596
Brief Title
The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO): Open Trial
Official Title
The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) : Open Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo Medical University
Collaborators
China Medical University, Taiwan, Japan Society for the Promotion of Science (JSPS), University of Toyama, Chiba University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Depression
Keywords
pregnant women, depression, depressive symptoms, omega-3 fatty acids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 polyunsaturated fatty acids
Arm Type
Experimental
Arm Description
1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 polyunsaturated fatty acids
Other Intervention Name(s)
1200mg EPA and 600mg DHA daily
Primary Outcome Measure Information:
Title
total score of the Hamilton Rating Scale for Depression (HAMD)
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
total score of HAMD
Time Frame
4-6 weeks after childbirth
Title
total scores on the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame
Twelve weeks, 4-6 weeks after childbirth
Title
total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)
Time Frame
Twelve weeks, 4-6 weeks after childbirth
Title
major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)
Time Frame
Twelve weeks, 4-6 weeks after childbirth
Title
omega-3 fatty acids concentrations in erythrocytes
Time Frame
Tweve weeks, 4-6 weeks after childbirth
Title
brain-derived neurotrophic factor (BDNF) in serum
Time Frame
Twelve weeks, 4-6 weeks after childbirth
Title
IF-6 in plasma
Time Frame
twelve weeks, 4-6 weeks after childbirth
Title
oxytocin in plasma
Time Frame
twelve weeks, 4-6 weeks after childbirth
Title
TNF-alpha in plasma
Time Frame
twelve weeks, 4-6 weeks after childbirth
Title
IL-1 beta in plasma
Time Frame
twelve weeks, 4-6 weeks after childbirth
Title
phospholipase A2 in plasma
Time Frame
twelve weeks, 4-6 weeks after childbirth
Other Pre-specified Outcome Measures:
Title
gestational age
Time Frame
at childbirth
Title
gestational diabetes mellitus
Time Frame
4-6 weeks after childbirth
Title
gestational hypertension or preeclampsia
Time Frame
4-6 weeks after childbirth
Title
induced labour
Time Frame
at childbirth
Title
estimated blood loss
Time Frame
at childbirth
Title
cesarean section
Time Frame
at childbirth
Title
operative vaginal delivery
Time Frame
at childbirth
Title
birthweight
Time Frame
at childbirth
Title
one minute apgar
Time Frame
4-6 weeks after childbirth
Title
5-minute apgar
Time Frame
4-6 weeks after childbirth
Title
neonatal intensive care unit admission
Time Frame
4-6 weeks after childbirth
Title
cholesterol
Time Frame
twelve weeks and 4-6 weeks after childbirth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women aged 20 years or older
between 12-24 weeks gestation
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
planned to return to the hospital for checkup at 4-6 weeks after childbirth
an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
to have good physical health judged by obstetricians.
Exclusion Criteria:
history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
the item of EPDS concerning suicide ideation is 2 or more
other serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
difficult to expect a normal birth (ex: fetal malformation etc.)
having a history of bleeding disorder such as von Willebrand's Disease
regular treatment with aspirin or warfarin within the last 3 months
a smoking habit of ≥40 cigarettes per day
regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
a habit of eating fish ≥4 times per week.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daisuke Nishi, M.D., Ph.D.
Organizational Affiliation
Tokyo Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kuan-Pin Su, M.D., Ph.D.
Organizational Affiliation
China Medical Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toda Maternity Hospital
City
Toda
State/Province
Saitama
Country
Japan
Facility Name
Tokyo Medical University
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8402
Country
Japan
Facility Name
China Medical University
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
27004997
Citation
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.
Results Reference
result
PubMed Identifier
28752805
Citation
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.
Results Reference
derived
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The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO): Open Trial
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