Skip to main content
OpenTrials
Completed

NCT Number: NCT07013981

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tokyo Medicial University

Shinjuku-Ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women aged 20 years or older.
  • between 12-24 weeks gestation.
  • a Japanese conversational ability to understand the scope of the present trial.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Omega-3 polyunsaturated fatty acids

Dietary Supplement

Other names: 1200mg EPA and 600mg DHA daily

Primary outcomes

  1. Total score of the Hamilton Rating Scale for Depression(HAMD)

    Time frame: Twelve weeks

    The Hamilton Rating Scale for Depression (HAMD) is a commonly used clinical tool for assessing the severity of depression. The most frequently used version, the HAMD-17, includes 17 items and has a total score range from 0 to 52. Higher scores indicate more severe depressive symptoms and thus a worse outcome, while lower scores suggest milder symptoms or improvement.

Secondary outcomes

  1. Total score of the Hamilton Rating Scale for Depression(HAMD)

    Time frame: 4-6 weeks after childbirth

    The Hamilton Rating Scale for Depression (HAMD) is a commonly used clinical tool for assessing the severity of depression. The most frequently used version, the HAMD-17, includes 17 items and has a total score range from 0 to 52. Higher scores indicate more severe depressive symptoms and thus a worse outcome, while lower scores suggest milder symptoms or improvement.

  2. Total scores on the Edinburgh Postnatal Depression Scale(EPDS)

    Time frame: Twelve weeks, 4-6 weeks after childbirth

    The Edinburgh Postnatal Depression Scale (EPDS) is a screening tool used to identify symptoms of postpartum depression. It consists of 10 items, each scored from 0 to 3, giving a minimum total score of 0 and a maximum total score of 30. Higher scores indicate more severe depressive symptoms, meaning a worse outcome, while lower scores suggest fewer or milder symptoms.

  3. Total score of the Beck Depression Inventory II (BDI-II)

    Time frame: Twelve weeks, 4-6 weeks after childbirth

    The Beck Depression Inventory-II (BDI-II) is a widely used self-report questionnaire designed to assess the severity of depressive symptoms. It includes 21 items, each scored from 0 to 3, resulting in a minimum total score of 0 and a maximum total score of 63. Higher scores indicate more severe depression, meaning a worse outcome, while lower scores reflect fewer or less severe symptoms.

  4. 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

  5. Omega-3 fatty acids concentrations in erythrocytes

    Time frame: Twelve weeks, 4-6 weeks after childbirth

  6. Brain-derived neurotrophic factor(BDNF)in serum

    Time frame: Twelve weeks, 4-6 weeks after childbirth

  7. Estrogen in serum

    Time frame: Twelve weeks, 4-6 weeks after childbirth

  8. Oxytocin in serum

    Time frame: Twelve weeks, 4-6 weeks after childbirth

  9. Progesterone in serum

    Time frame: Twelve weeks, 4-6 weeks after childbirth

  10. Human chorionic gonadotropin (hCG)in serum

    Time frame: Twelve weeks, 4-6 weeks after childbirth

  11. Phospholipase A2 in plasma

    Time frame: twelve weeks, 4-6 weeks after childbirth

Other outcomes

  1. Gestational age

    Time frame: 1 month after childbirth

  2. Gestational diabetes mellitus

    Time frame: 1 month after childbirth

  3. Gestational hypertension or preeclampsia

    Time frame: 1 month after childbirth

  4. Induced labor

    Time frame: 1 month after childbirth

  5. Estimated blood loss

    Time frame: 1 month after childbirth

  6. Cesarean section

    Time frame: 1 month after childbirth

  7. Operative vaginal delivery

    Time frame: 1 month after childbirth

  8. Birthweight

    Time frame: 1 month after childbirth

  9. 1-min and 5-min Apgar scores

    Time frame: 1 month after childbirth

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Collaborators

  • Chiba University
  • Japanese Society for the Promotion of Science
  • University of Toyama

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.