Clinical trial NCT02166424: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)
Official title: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Depression
Keywords: Pregnancy
Depression
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
name: National Center for Child Health and Development
First posted: 2014-06-18
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_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.

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.)

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 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.

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: 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: 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: 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: estrogen in plasma
timeFrame: twelve weeks, 4-6 weeks after childbirth
measure: oxytocin in plasma
timeFrame: twelve weeks, 4-6 weeks after childbirth
measure: progesterone in plasma
timeFrame: twelve weeks, 4-6 weeks after childbirth
measure: human chorionic gonadotropin (hCG) 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 apger
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 Chuo Women's Hospital
state: Saitama
city: Setagaya
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Shinjyuku-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, 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.