Clinical trial NCT01948596: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO): Open Trial
Official title: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) : Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Depression
Keywords: pregnant women
depression
depressive symptoms
omega-3 fatty acids
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
Collaborators: name: China Medical University, Taiwan
name: Japan Society for the Promotion of Science (JSPS)
name: University of Toyama
name: Chiba University
First posted: 2013-09-23
Enrollment: 13
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.

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.

Eligibility criteria: 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 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 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: Tweve weeks, 4-6 weeks after childbirth
measure: brain-derived neurotrophic factor (BDNF) in serum
timeFrame: Twelve weeks, 4-6 weeks after childbirth
measure: IF-6 in plasma
timeFrame: twelve weeks, 4-6 weeks after childbirth
measure: oxytocin in plasma
timeFrame: twelve weeks, 4-6 weeks after childbirth
measure: TNF-alpha in plasma
timeFrame: twelve weeks, 4-6 weeks after childbirth
measure: IL-1 beta in plasma
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: at childbirth
measure: gestational diabetes mellitus
timeFrame: 4-6 weeks after childbirth
measure: gestational hypertension or preeclampsia
timeFrame: 4-6 weeks after childbirth
measure: induced labour
timeFrame: at childbirth
measure: estimated blood loss
timeFrame: at childbirth
measure: cesarean section
timeFrame: at childbirth
measure: operative vaginal delivery
timeFrame: at childbirth
measure: birthweight
timeFrame: at childbirth
measure: one minute apgar
timeFrame: 4-6 weeks after childbirth
measure: 5-minute apgar
timeFrame: 4-6 weeks after childbirth
measure: neonatal intensive care unit admission
timeFrame: 4-6 weeks after childbirth
measure: cholesterol
timeFrame: twelve weeks and 4-6 weeks after childbirth
Locations:
city: Toda
country: Japan
facility: Toda Maternity Hospital
state: Saitama
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University
state: Tokyo
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: Tokyo Medical University
name: Daisuke Nishi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical Univeristy
name: Kuan-Pin Su, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nishi D, Su KP, Usuda K, Chiang YJ, Guu TW, Hamazaki K, Nakaya N, Sone T, Sano Y, Ito H, Isaka K, Hashimoto K, Hamazaki T, Matsuoka YJ. Omega-3 fatty acid supplementation for expectant mothers with depressive symptoms in Japan and Taiwan: An open-label trial. Psychiatry Clin Neurosci. 2016 Jun;70(6):253-4. doi: 10.1111/pcn.12388. Epub 2016 May 6. No abstract available.
citation: Nishi D, Su KP, Usuda K, Chang JP, Chiang YJ, Guu TW, Hamazaki K, Nakaya N, Sone T, Hashimoto K, Hamazaki T, Matsuoka YJ. Differences between Japan and Taiwan in the treatment of pregnant women with depressive symptoms by omega-3 fatty acids: An open-label pilot study. Nutr Neurosci. 2019 Jan;22(1):63-71. doi: 10.1080/1028415X.2017.1354540. Epub 2017 Jul 28.