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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948596
• Other study ID #: SYNCHRO-Open
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2013
• Last updated: April 19, 2016
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: Tokyo Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• 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 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Pregnancy

Intervention

Dietary Supplement:
• Omega-3 polyunsaturated fatty acids

Locations

Country	Name	City	State
Japan	Tokyo Medical University	Shinjuku-ku	Tokyo
Japan	Toda Maternity Hospital	Toda	Saitama
Taiwan	China Medical University	Taichung

Sponsors (5)

Lead Sponsor	Collaborator
Tokyo Medical University	Chiba University, China Medical University, Taiwan, Japan Society for the Promotion of Science (JSPS), University of Toyama

Countries where clinical trial is conducted

Japan,  Taiwan, 

References & Publications (1)

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 tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gestational age		at childbirth	No
Other	gestational diabetes mellitus		4-6 weeks after childbirth	Yes
Other	gestational hypertension or preeclampsia		4-6 weeks after childbirth	Yes
Other	induced labour		at childbirth	Yes
Other	estimated blood loss		at childbirth	Yes
Other	cesarean section		at childbirth	Yes
Other	operative vaginal delivery		at childbirth	Yes
Other	birthweight		at childbirth	No
Other	one minute apgar		4-6 weeks after childbirth	Yes
Other	5-minute apgar		4-6 weeks after childbirth	Yes
Other	neonatal intensive care unit admission		4-6 weeks after childbirth	Yes
Other	cholesterol		twelve weeks and 4-6 weeks after childbirth	No
Primary	total score of the Hamilton Rating Scale for Depression (HAMD)		Twelve weeks	Yes
Secondary	total score of HAMD		4-6 weeks after childbirth	Yes
Secondary	total scores on the Edinburgh Postnatal Depression Scale (EPDS)		Twelve weeks, 4-6 weeks after childbirth	Yes
Secondary	total score of the Beck Depression Inventory ?(BDI-?)		Twelve weeks, 4-6 weeks after childbirth	Yes
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	Yes
Secondary	omega-3 fatty acids concentrations in erythrocytes		Tweve weeks, 4-6 weeks after childbirth	No
Secondary	brain-derived neurotrophic factor (BDNF) in serum		Twelve weeks, 4-6 weeks after childbirth	No
Secondary	IF-6 in plasma		twelve weeks, 4-6 weeks after childbirth	No
Secondary	oxytocin in plasma		twelve weeks, 4-6 weeks after childbirth	No
Secondary	TNF-alpha in plasma		twelve weeks, 4-6 weeks after childbirth	No
Secondary	IL-1 beta in plasma		twelve weeks, 4-6 weeks after childbirth	No
Secondary	phospholipase A2 in plasma		twelve weeks, 4-6 weeks after childbirth	No