The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)

Tokyo Medical University4 sites in 2 countries108 target enrollmentJune 2014

ConditionsPregnancy Depression

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pregnancy
Sponsor: Tokyo Medical University
Enrollment: 108
Locations: 4
Primary Endpoint: total score of the Hamilton Rating Scale for Depression (HAMD)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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. (Participants who skipped taking supplements for more than 7 days will be excluded from a per protocol analysis.)

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Tokyo Medical University

Responsible Party

Principal Investigator

Daisuke Nishi

Assistant Professor

Tokyo Medical University

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 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.

Outcomes

Primary Outcomes

total score of the Hamilton Rating Scale for Depression (HAMD)

Time Frame: Twelve weeks

Secondary Outcomes

total score of HAMD(4-6 weeks after childbirth)
major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)(Twelve weeks, 4-6 weeks after childbirth)
total scores on the Edinburgh Postnatal Depression Scale (EPDS)(Twelve weeks, 4-6 weeks after childbirth)
total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)(Twelve weeks, 4-6 weeks after childbirth)
omega-3 fatty acids concentrations in erythrocytes(Tweve weeks, 4-6 weeks after childbirth)
brain-derived neurotrophic factor (BDNF) in serum(Twelve weeks, 4-6 weeks after childbirth)
estrogen in plasma(twelve weeks, 4-6 weeks after childbirth)
oxytocin in plasma(twelve weeks, 4-6 weeks after childbirth)
progesterone in plasma(twelve weeks, 4-6 weeks after childbirth)
human chorionic gonadotropin (hCG) in plasma(twelve weeks, 4-6 weeks after childbirth)
phospholipase A2 in plasma(twelve weeks, 4-6 weeks after childbirth)