- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02166424
The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)
December 19, 2017 updated by: Daisuke Nishi, Tokyo Medical University
The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
(Participants who skipped taking supplements for more than 7 days will be excluded from a per protocol analysis.)
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 take assessments 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
- 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 as a main dish ≥4 times per week.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Omega-3 polyunsaturated fatty acids
1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
|
Other Names:
|
Placebo Comparator: olive oil
2880mg olive oil daily
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total score of the Hamilton Rating Scale for Depression (HAMD)
Time Frame: Twelve weeks
|
Twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total score of HAMD
Time Frame: 4-6 weeks after childbirth
|
4-6 weeks after childbirth
|
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
|
Twelve weeks, 4-6 weeks after childbirth
|
total scores on the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Twelve weeks, 4-6 weeks after childbirth
|
Twelve weeks, 4-6 weeks after childbirth
|
total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)
Time Frame: Twelve weeks, 4-6 weeks after childbirth
|
Twelve weeks, 4-6 weeks after childbirth
|
omega-3 fatty acids concentrations in erythrocytes
Time Frame: Tweve weeks, 4-6 weeks after childbirth
|
Tweve weeks, 4-6 weeks after childbirth
|
brain-derived neurotrophic factor (BDNF) in serum
Time Frame: Twelve weeks, 4-6 weeks after childbirth
|
Twelve weeks, 4-6 weeks after childbirth
|
estrogen in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
|
twelve weeks, 4-6 weeks after childbirth
|
oxytocin in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
|
twelve weeks, 4-6 weeks after childbirth
|
progesterone in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
|
twelve weeks, 4-6 weeks after childbirth
|
human chorionic gonadotropin (hCG) in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
|
twelve weeks, 4-6 weeks after childbirth
|
phospholipase A2 in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
|
twelve weeks, 4-6 weeks after childbirth
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
gestational age
Time Frame: at childbirth
|
at childbirth
|
gestational diabetes mellitus
Time Frame: 4-6 weeks after childbirth
|
4-6 weeks after childbirth
|
gestational hypertension or preeclampsia
Time Frame: 4-6 weeks after childbirth
|
4-6 weeks after childbirth
|
induced labour
Time Frame: at childbirth
|
at childbirth
|
estimated blood loss
Time Frame: at childbirth
|
at childbirth
|
cesarean section
Time Frame: at childbirth
|
at childbirth
|
operative vaginal delivery
Time Frame: at childbirth
|
at childbirth
|
birthweight
Time Frame: at childbirth
|
at childbirth
|
one minute apger
Time Frame: 4-6 weeks after childbirth
|
4-6 weeks after childbirth
|
5-minute apgar
Time Frame: 4-6 weeks after childbirth
|
4-6 weeks after childbirth
|
neonatal intensive care unit admission
Time Frame: 4-6 weeks after childbirth
|
4-6 weeks after childbirth
|
cholesterol
Time Frame: twelve weeks and 4-6 weeks after childbirth
|
twelve weeks and 4-6 weeks after childbirth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
June 15, 2014
First Submitted That Met QC Criteria
June 15, 2014
First Posted (Estimate)
June 18, 2014
Study Record Updates
Last Update Posted (Actual)
December 21, 2017
Last Update Submitted That Met QC Criteria
December 19, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYNCHRO-RCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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