Depressive Symptoms
Conditions
Brief summary
The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
Interventions
DIETARY_SUPPLEMENTOmega-3 polyunsaturated fatty acids
Sponsors
Japanese Society for the Promotion of Science
University of Toyama
Chiba University
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total score of the Hamilton Rating Scale for Depression(HAMD) | 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
| Measure | Time frame | Description |
|---|---|---|
| Total scores on the Edinburgh Postnatal Depression Scale(EPDS) | 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. |
| Total score of the Beck Depression Inventory II (BDI-II) | 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. |
| 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 | — |
| Brain-derived neurotrophic factor(BDNF)in serum | Twelve weeks, 4-6 weeks after childbirth | — |
| Estrogen in serum | Twelve weeks, 4-6 weeks after childbirth | — |
| Oxytocin in serum | Twelve weeks, 4-6 weeks after childbirth | — |
| Progesterone in serum | Twelve weeks, 4-6 weeks after childbirth | — |
| Human chorionic gonadotropin (hCG)in serum | Twelve weeks, 4-6 weeks after childbirth | — |
| Phospholipase A2 in plasma | twelve weeks, 4-6 weeks after childbirth | — |
| Total score of the Hamilton Rating Scale for Depression(HAMD) | 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. |
Other
| Measure | Time frame |
|---|---|
| Gestational hypertension or preeclampsia | 1 month after childbirth |
| Induced labor | 1 month after childbirth |
| Estimated blood loss | 1 month after childbirth |
| Cesarean section | 1 month after childbirth |
| Operative vaginal delivery | 1 month after childbirth |
| Birthweight | 1 month after childbirth |
| 1-min and 5-min Apgar scores | 1 month after childbirth |
| Gestational diabetes mellitus | 1 month after childbirth |
| Gestational age | 1 month after childbirth |
Countries
Japan
Outcome results
None listed