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

National Science and Technology Council, Taiwan5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Depressive Symptoms

Interventions

Omega-3 polyunsaturated fatty acidsDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. pregnant women aged 20 years or older. 2. between 12-24 weeks gestation. 3. a Japanese conversational ability to understand the scope of the present trial. 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.

Locations (1)

Tokyo Medicial University

Shinjuku-Ku, Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: Twelve weeks

Secondary Outcomes

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

Time frame: 4-6 weeks after childbirth

Total scores on the Edinburgh Postnatal Depression Scale(EPDS)

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.

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

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

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.