Pregnancy, Depression
Conditions
Keywords
Pregnancy, Depression, omega-3 fatty acids
Brief summary
The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
Detailed description
Maternal depression can have a significant harmful influence on both mothers and children. Considering the possibility of adverse effects of antidepressants and previous meta-analyses showing the positive effects of omega-3 polyunsaturated fatty acids (PUFAs) supplementation in reducing depressive symptoms, omega-3 PUFAs may provide a safe strategy. The investigators evaluate efficacy and safety of omega-3 PUFAs for pregnant women with depressive symptoms. (Participants who skipped taking supplements for more than 7 days will be excluded from a per protocol analysis.)
Interventions
DIETARY_SUPPLEMENTOmega-3 polyunsaturated fatty acids
DIETARY_SUPPLEMENTOlive oil
Sponsors
China Medical University, Taiwan
Japan Society for the Promotion of Science (JSPS)
University of Toyama
Chiba University
National Center for Child Health and Development
Tokyo Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. pregnant women aged 20 years or older 2. between 12-24 weeks gestation 3. a Japanese conversational ability in Japan site or a Mandarin conversational ability in Taiwan site to understand the scope of the present trial and to provide written consent for study participation 4. planned to take assessments 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. Serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment 3. difficult to expect a normal birth (ex: fetal malformation etc.) 4. having a history of bleeding disorder such as von Willebrand's Disease 5. regular treatment with aspirin or warfarin within the last 3 months 6. a smoking habit of ≥40 cigarettes per day 7. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months 8. a habit of eating fish as a main dish ≥4 times per week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total score of the Hamilton Rating Scale for Depression (HAMD) | Twelve weeks |
Secondary
| Measure | Time frame |
|---|---|
| total score of HAMD | 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 |
| 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 |
| omega-3 fatty acids concentrations in erythrocytes | Tweve weeks, 4-6 weeks after childbirth |
| brain-derived neurotrophic factor (BDNF) in serum | Twelve weeks, 4-6 weeks after childbirth |
| estrogen in plasma | twelve weeks, 4-6 weeks after childbirth |
| oxytocin in plasma | twelve weeks, 4-6 weeks after childbirth |
| progesterone in plasma | twelve weeks, 4-6 weeks after childbirth |
| human chorionic gonadotropin (hCG) in plasma | twelve weeks, 4-6 weeks after childbirth |
| phospholipase A2 in plasma | twelve weeks, 4-6 weeks after childbirth |
Other
| Measure | Time frame |
|---|---|
| gestational age | at childbirth |
| gestational diabetes mellitus | 4-6 weeks after childbirth |
| gestational hypertension or preeclampsia | 4-6 weeks after childbirth |
| induced labour | at childbirth |
| estimated blood loss | at childbirth |
| cesarean section | at childbirth |
| operative vaginal delivery | at childbirth |
| birthweight | at childbirth |
| one minute apger | 4-6 weeks after childbirth |
| 5-minute apgar | 4-6 weeks after childbirth |
| neonatal intensive care unit admission | 4-6 weeks after childbirth |
| cholesterol | twelve weeks and 4-6 weeks after childbirth |
Countries
Japan, Taiwan
Outcome results
None listed