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

NCT02166424 | Completed Phase 3 DMC

• 1 other identifier: SYNCHRO-RCT
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 4

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

Pregnancy; Depression; 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

• 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

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 (2)

Omega-3 polyunsaturated fatty acids

ACTIVE COMPARATOR

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

Dietary Supplement: Omega-3 polyunsaturated fatty acids

olive oil

PLACEBO COMPARATOR

2880mg olive oil daily

Dietary Supplement: Olive oil

Interventions

Omega-3 polyunsaturated fatty acids DIETARY_SUPPLEMENT

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

Omega-3 polyunsaturated fatty acids

Olive oil DIETARY_SUPPLEMENT

Also known as: 2880mg olive oil daily

olive oil

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 take assessments 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
• 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.

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
• National Center for Child Health and Development: collaborator

Study Sites (4)

Toda Chuo Women's Hospital

Toda, Saitama, 335-0022, Japan

Location

National Center for Child Health and Development

Setagaya City, Tokyo, Japan

Location

Tokyo Medical University

Shinjyuku-ku, Tokyo, 160-8402, Japan

Location

China Medical University

Taichung, Taiwan

Location

Related Publications (1)

• Nishi D, Su KP, Usuda K, Chiang YJ, Guu TW, Hamazaki K, Nakaya N, Sone T, Sano Y, Tachibana Y, Ito H, Isaka K, Hashimoto K, Hamazaki T, Matsuoka YJ. The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Sep 15;16(1):321. doi: 10.1186/s12888-016-1031-2.

  PMID: 27630014 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Docosahexaenoic Acids; Olive Oil

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; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

TW (1); JP (3)