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

National Science and Technology Council, Taiwan

Status: Completed

Conditions: Depressive Symptoms

Treatments: Dietary Supplement: Omega-3 polyunsaturated fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT07013981

CMUH102-REC1-060

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 2 patient groups, including a placebo group

Omega-3 polyunsaturated fatty acids

Experimental group

Description:

1200mg EPA and 600mg DHA daily

Treatment:

Dietary Supplement: Omega-3 polyunsaturated fatty acids

Dietary Supplement: Omega-3 polyunsaturated fatty acids

Placebo Comparator

Placebo Comparator group

Description:

320 mg olive oil and 9.9 mg omega-3 PUFAs

Treatment:

Dietary Supplement: Omega-3 polyunsaturated fatty acids

Dietary Supplement: Omega-3 polyunsaturated fatty acids