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| Name | Class |
|---|---|
| China Medical University, Taiwan | OTHER |
| Japan Society for the Promotion of Science (JSPS) | UNKNOWN |
| University of Toyama | OTHER |
| Chiba University |
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The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 polyunsaturated fatty acids | Active Comparator | 1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily |
|
| olive oil | Placebo Comparator | 2880mg olive oil daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 polyunsaturated fatty acids | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| total score of the Hamilton Rating Scale for Depression (HAMD) | Twelve weeks |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| gestational age | at childbirth | |
| gestational diabetes mellitus | 4-6 weeks after childbirth | |
| gestational hypertension or preeclampsia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daisuke Nishi, M.D., Ph.D. | Tokyo Medical University | Principal Investigator |
| Kuan-Pin Su, M.D., Ph.D. | China Medical Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toda Chuo Women's Hospital | Toda | Saitama | 335-0022 | Japan | ||
| National Center for Child Health and Development |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27630014 | Derived | Nishi D, Su KP, Usuda K, Chiang YJ, Guu TW, Hamazaki K, Nakaya N, Sone T, Sano Y, Tachibana Y, Ito H, Isaka K, Hashimoto K, Hamazaki T, Matsuoka YJ. The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Sep 15;16(1):321. doi: 10.1186/s12888-016-1031-2. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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| Olive oil | Dietary Supplement |
|
|
| 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 |
| 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 |
| Setagaya City |
| Tokyo |
| Japan |
| Tokyo Medical University | Shinjyuku-ku | Tokyo | 160-8402 | Japan |
| China Medical University | Taichung | Taiwan |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |