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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02166424
Other study ID # SYNCHRO-RCT
Secondary ID
Status Completed
Phase Phase 3
First received June 15, 2014
Last updated December 19, 2017
Start date June 2014
Est. completion date December 2017

Study information

Verified date December 2017
Source Tokyo Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.


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.)


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Omega-3 polyunsaturated fatty acids

Olive oil


Locations

Country Name City State
Japan National Center for Child Health and Development Setagaya Tokyo
Japan Tokyo Medical University Shinjyuku-ku Tokyo
Japan Toda Chuo Women's Hospital Toda Saitama
Taiwan China Medical University Taichung

Sponsors (6)

Lead Sponsor Collaborator
Tokyo Medical University Chiba University, China Medical University, Taiwan, Japan Society for the Promotion of Science (JSPS), National Center for Child Health and Development, University of Toyama

Countries where clinical trial is conducted

Japan,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other gestational age at childbirth
Other gestational diabetes mellitus 4-6 weeks after childbirth
Other gestational hypertension or preeclampsia 4-6 weeks after childbirth
Other induced labour at childbirth
Other estimated blood loss at childbirth
Other cesarean section at childbirth
Other operative vaginal delivery at childbirth
Other birthweight at childbirth
Other one minute apger 4-6 weeks after childbirth
Other 5-minute apgar 4-6 weeks after childbirth
Other neonatal intensive care unit admission 4-6 weeks after childbirth
Other cholesterol twelve weeks and 4-6 weeks after childbirth
Primary total score of the Hamilton Rating Scale for Depression (HAMD) Twelve weeks
Secondary total score of HAMD 4-6 weeks after childbirth
Secondary major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI) Twelve weeks, 4-6 weeks after childbirth
Secondary total scores on the Edinburgh Postnatal Depression Scale (EPDS) Twelve weeks, 4-6 weeks after childbirth
Secondary total score of the Beck Depression Inventory ?(BDI-?) Twelve weeks, 4-6 weeks after childbirth
Secondary omega-3 fatty acids concentrations in erythrocytes Tweve weeks, 4-6 weeks after childbirth
Secondary brain-derived neurotrophic factor (BDNF) in serum Twelve weeks, 4-6 weeks after childbirth
Secondary estrogen in plasma twelve weeks, 4-6 weeks after childbirth
Secondary oxytocin in plasma twelve weeks, 4-6 weeks after childbirth
Secondary progesterone in plasma twelve weeks, 4-6 weeks after childbirth
Secondary human chorionic gonadotropin (hCG) in plasma twelve weeks, 4-6 weeks after childbirth
Secondary phospholipase A2 in plasma twelve weeks, 4-6 weeks after childbirth
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