The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)

Depression Clinical Trial

Official title:

The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166424
• Other study ID #: SYNCHRO-RCT
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Pregnancy

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