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

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ClinicalTrials.gov Identifier: NCT01948596
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : April 21, 2016
Sponsor:
Collaborators:
China Medical University, Taiwan
Japan Society for the Promotion of Science (JSPS)
University of Toyama
Chiba University
Information provided by (Responsible Party):
Daisuke Nishi, Tokyo Medical University

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

Condition or disease Intervention/treatment Phase
Pregnancy Depression Dietary Supplement: Omega-3 polyunsaturated fatty acids Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) : Open Trial
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Omega-3 polyunsaturated fatty acids
1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
Dietary Supplement: Omega-3 polyunsaturated fatty acids
Other Name: 1200mg EPA and 600mg DHA daily




Primary Outcome Measures :
  1. total score of the Hamilton Rating Scale for Depression (HAMD) [ Time Frame: Twelve weeks ]

Secondary Outcome Measures :
  1. total score of HAMD [ Time Frame: 4-6 weeks after childbirth ]
  2. total scores on the Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Twelve weeks, 4-6 weeks after childbirth ]
  3. total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ) [ Time Frame: Twelve weeks, 4-6 weeks after childbirth ]
  4. major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI) [ Time Frame: Twelve weeks, 4-6 weeks after childbirth ]
  5. omega-3 fatty acids concentrations in erythrocytes [ Time Frame: Tweve weeks, 4-6 weeks after childbirth ]
  6. brain-derived neurotrophic factor (BDNF) in serum [ Time Frame: Twelve weeks, 4-6 weeks after childbirth ]
  7. IF-6 in plasma [ Time Frame: twelve weeks, 4-6 weeks after childbirth ]
  8. oxytocin in plasma [ Time Frame: twelve weeks, 4-6 weeks after childbirth ]
  9. TNF-alpha in plasma [ Time Frame: twelve weeks, 4-6 weeks after childbirth ]
  10. IL-1 beta in plasma [ Time Frame: twelve weeks, 4-6 weeks after childbirth ]
  11. phospholipase A2 in plasma [ Time Frame: twelve weeks, 4-6 weeks after childbirth ]

Other Outcome Measures:
  1. gestational age [ Time Frame: at childbirth ]
  2. gestational diabetes mellitus [ Time Frame: 4-6 weeks after childbirth ]
  3. gestational hypertension or preeclampsia [ Time Frame: 4-6 weeks after childbirth ]
  4. induced labour [ Time Frame: at childbirth ]
  5. estimated blood loss [ Time Frame: at childbirth ]
  6. cesarean section [ Time Frame: at childbirth ]
  7. operative vaginal delivery [ Time Frame: at childbirth ]
  8. birthweight [ Time Frame: at childbirth ]
  9. one minute apgar [ Time Frame: 4-6 weeks after childbirth ]
  10. 5-minute apgar [ Time Frame: 4-6 weeks after childbirth ]
  11. neonatal intensive care unit admission [ Time Frame: 4-6 weeks after childbirth ]
  12. cholesterol [ Time Frame: twelve weeks and 4-6 weeks after childbirth ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948596


Locations
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Japan
Toda Maternity Hospital
Toda, Saitama, Japan
Tokyo Medical University
Shinjuku-ku, Tokyo, Japan, 160-8402
Taiwan
China Medical University
Taichung, Taiwan
Sponsors and Collaborators
Tokyo Medical University
China Medical University, Taiwan
Japan Society for the Promotion of Science (JSPS)
University of Toyama
Chiba University
Investigators
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Principal Investigator: Daisuke Nishi, M.D., Ph.D. Tokyo Medical University
Principal Investigator: Kuan-Pin Su, M.D., Ph.D. China Medical Univeristy

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daisuke Nishi, Assistant Professor, Tokyo Medical University
ClinicalTrials.gov Identifier: NCT01948596     History of Changes
Other Study ID Numbers: SYNCHRO-Open
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Daisuke Nishi, Tokyo Medical University:
pregnant women
depression
depressive symptoms
omega-3 fatty acids

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms