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

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

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: Depression; Pregnancy
• Intervention / Treatment: Dietary supplement: Omega-3 polyunsaturated fatty acids

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Saitama
    • Toda, Saitama, Japan
      • Toda Maternity Hospital
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-8402
      • Tokyo Medical University
• Taiwan
  • Taichung, Taiwan
    • China Medical University

Participation Criteria

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:

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 return to the hospital for checkup at 4-6 weeks after childbirth
5. an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
6. to have good physical health judged by obstetricians.

Exclusion Criteria:

1. history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
2. the item of EPDS concerning suicide ideation is 2 or more
3. other serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
4. difficult to expect a normal birth (ex: fetal malformation etc.)
5. having a history of bleeding disorder such as von Willebrand's Disease
6. regular treatment with aspirin or warfarin within the last 3 months
7. a smoking habit of ≥40 cigarettes per day
8. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
9. a habit of eating fish ≥4 times per week.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega-3 polyunsaturated fatty acids; 1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily	Dietary supplement: Omega-3 polyunsaturated fatty acids; Other Names: 1200mg EPA and 600mg DHA daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total score of the Hamilton Rating Scale for Depression (HAMD)	Twelve weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
oxytocin in plasma	twelve weeks, 4-6 weeks after childbirth
phospholipase A2 in plasma	twelve weeks, 4-6 weeks after childbirth
IF-6 in plasma	twelve weeks, 4-6 weeks after childbirth
TNF-alpha in plasma	twelve weeks, 4-6 weeks after childbirth
IL-1 beta in plasma	twelve weeks, 4-6 weeks after childbirth

Other Outcome Measures

Outcome Measure	Time Frame
gestational age	at childbirth
gestational diabetes mellitus	4-6 weeks after childbirth
gestational hypertension or preeclampsia	4-6 weeks after childbirth
induced labour	at childbirth
estimated blood loss	at childbirth
cesarean section	at childbirth
operative vaginal delivery	at childbirth
birthweight	at childbirth
5-minute apgar	4-6 weeks after childbirth
neonatal intensive care unit admission	4-6 weeks after childbirth
cholesterol	twelve weeks and 4-6 weeks after childbirth
one minute apgar	4-6 weeks after childbirth

Collaborators and Investigators

• Sponsor: Tokyo Medical University
• Collaborators: University of Toyama; China Medical University, Taiwan; Chiba University; Japan Society for the Promotion of Science (JSPS)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: depression; pregnant women; omega-3 fatty acids; depressive symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: SYNCHRO-Open