Clinical trial NCT07013981: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)in Tokyo: Open Trial
Official title: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)in Tokyo: Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Japanese Society for the Promotion of Science
name: University of Toyama
name: Chiba University
First posted: 2025-06-10
Enrollment: 5
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Total score of the Hamilton Rating Scale for Depression(HAMD)
timeFrame: Twelve weeks
Secondary outcomes:
measure: Total score of the Hamilton Rating Scale for Depression(HAMD)
timeFrame: 4-6 weeks after childbirth
measure: Total scores on the Edinburgh Postnatal Depression Scale(EPDS)
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Total score of the Beck Depression Inventory II (BDI-II)
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Major depressive disorder(MDD)as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Omega-3 fatty acids concentrations in erythrocytes
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Brain-derived neurotrophic factor(BDNF)in serum
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Estrogen in serum
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Oxytocin in serum
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Progesterone in serum
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Human chorionic gonadotropin (hCG)in serum
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: Phospholipase A2 in plasma
timeFrame: twelve weeks, 4-6 weeks after childbirth
Other outcomes:
measure: Gestational age
timeFrame: 1 month after childbirth
measure: Gestational diabetes mellitus
timeFrame: 1 month after childbirth
measure: Gestational hypertension or preeclampsia
timeFrame: 1 month after childbirth
measure: Induced labor
timeFrame: 1 month after childbirth
measure: Estimated blood loss
timeFrame: 1 month after childbirth
measure: Cesarean section
timeFrame: 1 month after childbirth
measure: Operative vaginal delivery
timeFrame: 1 month after childbirth
measure: Birthweight
timeFrame: 1 month after childbirth
measure: 1-min and 5-min Apgar scores
timeFrame: 1 month after childbirth
Locations:
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medicial University
state: Tokyo
Study officials:
References: