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

April 19, 2016 updated by: Daisuke Nishi, Tokyo Medical University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Saitama
      • Toda, Saitama, Japan
        • Toda Maternity Hospital
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8402
        • Tokyo Medical University
  • Taiwan
      • Taichung, Taiwan
        • China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Omega-3 polyunsaturated fatty acids
1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
Dietary supplement: Omega-3 polyunsaturated fatty acids
Other Names:
  • 1200mg EPA and 600mg DHA daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
total score of the Hamilton Rating Scale for Depression (HAMD)
Time Frame: Twelve weeks
Twelve weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
total score of HAMD
Time Frame: 4-6 weeks after childbirth
4-6 weeks after childbirth
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
Twelve weeks, 4-6 weeks after childbirth
total scores on the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Twelve weeks, 4-6 weeks after childbirth
Twelve weeks, 4-6 weeks after childbirth
total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)
Time Frame: Twelve weeks, 4-6 weeks after childbirth
Twelve weeks, 4-6 weeks after childbirth
omega-3 fatty acids concentrations in erythrocytes
Time Frame: Tweve weeks, 4-6 weeks after childbirth
Tweve weeks, 4-6 weeks after childbirth
brain-derived neurotrophic factor (BDNF) in serum
Time Frame: Twelve weeks, 4-6 weeks after childbirth
Twelve weeks, 4-6 weeks after childbirth
oxytocin in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
twelve weeks, 4-6 weeks after childbirth
phospholipase A2 in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
twelve weeks, 4-6 weeks after childbirth
IF-6 in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
twelve weeks, 4-6 weeks after childbirth
TNF-alpha in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
twelve weeks, 4-6 weeks after childbirth
IL-1 beta in plasma
Time Frame: twelve weeks, 4-6 weeks after childbirth
twelve weeks, 4-6 weeks after childbirth

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
gestational age
Time Frame: at childbirth
at childbirth
gestational diabetes mellitus
Time Frame: 4-6 weeks after childbirth
4-6 weeks after childbirth
gestational hypertension or preeclampsia
Time Frame: 4-6 weeks after childbirth
4-6 weeks after childbirth
induced labour
Time Frame: at childbirth
at childbirth
estimated blood loss
Time Frame: at childbirth
at childbirth
cesarean section
Time Frame: at childbirth
at childbirth
operative vaginal delivery
Time Frame: at childbirth
at childbirth
birthweight
Time Frame: at childbirth
at childbirth
5-minute apgar
Time Frame: 4-6 weeks after childbirth
4-6 weeks after childbirth
neonatal intensive care unit admission
Time Frame: 4-6 weeks after childbirth
4-6 weeks after childbirth
cholesterol
Time Frame: twelve weeks and 4-6 weeks after childbirth
twelve weeks and 4-6 weeks after childbirth
one minute apgar
Time Frame: 4-6 weeks after childbirth
4-6 weeks after childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokyo Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Toyama
China Medical University, Taiwan
Chiba University
Japan Society for the Promotion of Science (JSPS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYNCHRO-Open

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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