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

NCT01948596 | Completed Phase 2 DMC

• 1 other identifier: SYNCHRO-Open
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 3

Brief Summary

The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

Conditions

Pregnancy; Depression

Keywords

pregnant women; depression; depressive symptoms; omega-3 fatty acids

Outcome Measures

Primary Outcomes (1)

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

  Twelve weeks

Secondary Outcomes (11)

• total score of HAMD

  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

• major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)

  Twelve weeks, 4-6 weeks after childbirth

• omega-3 fatty acids concentrations in erythrocytes

  Tweve weeks, 4-6 weeks after childbirth

Other Outcomes (12)

• gestational age

  at childbirth

• gestational diabetes mellitus

  4-6 weeks after childbirth

• gestational hypertension or preeclampsia

  4-6 weeks after childbirth

Study Arms (1)

Omega-3 polyunsaturated fatty acids

EXPERIMENTAL

1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily

Dietary Supplement: Omega-3 polyunsaturated fatty acids

Interventions

Omega-3 polyunsaturated fatty acids DIETARY_SUPPLEMENT

Also known as: 1200mg EPA and 600mg DHA daily

Omega-3 polyunsaturated fatty acids

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Toda Maternity Hospital

Toda, Saitama, Japan

Location

Tokyo Medical University

Shinjuku-ku, Tokyo, 160-8402, Japan

Location

China Medical University

Taichung, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 27004997 RESULT

• 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.

  PMID: 28752805 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Daisuke Nishi, M.D., Ph.D.

  Tokyo Medical University

  PRINCIPAL INVESTIGATOR

• Kuan-Pin Su, M.D., Ph.D.

  China Medical Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 23, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

JP (2); TW (1)