NCT07013981

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2017

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

4.3 years

First QC Date

October 7, 2022

Last Update Submit

June 2, 2025

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

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

    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.

    Twelve weeks

Secondary Outcomes (11)

  • Total score of the Hamilton Rating Scale for Depression(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

    Twelve weeks, 4-6 weeks after childbirth

  • +6 more secondary outcomes

Other Outcomes (9)

  • Gestational age

    1 month after childbirth

  • Gestational diabetes mellitus

    1 month after childbirth

  • Gestational hypertension or preeclampsia

    1 month after childbirth

  • +6 more other outcomes

Study Arms (2)

Omega-3 polyunsaturated fatty acids

EXPERIMENTAL

1200mg EPA and 600mg DHA daily

Dietary Supplement: Omega-3 polyunsaturated fatty acids

Placebo Comparator

PLACEBO COMPARATOR

320 mg olive oil and 9.9 mg omega-3 PUFAs

Dietary Supplement: Omega-3 polyunsaturated fatty acids

Interventions

Omega-3 polyunsaturated fatty acidsDIETARY_SUPPLEMENT
Also known as: 1200mg EPA and 600mg DHA daily
Omega-3 polyunsaturated fatty acids

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo Medicial University

Shinjuku-Ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Depression

Interventions

Docosahexaenoic AcidsOlive Oil

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2022

First Posted

June 10, 2025

Study Start

January 9, 2013

Primary Completion

May 11, 2017

Study Completion

November 11, 2017

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations

JP(1)