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PregnancyPhase 3NCT02166424

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

A Phase 3 study testing Omega-3 polyunsaturated fatty acids and Olive oil in people with Pregnancy and Depression, run by Tokyo Medical University at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Pregnancy, Depression
What is being tested?
Omega-3 polyunsaturated fatty acids and Olive oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
4 sitesin 2 countries
Study dates
Jun 2014to Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pregnant women aged 20 years or older
  • between 12-24 weeks gestation
  • 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
  • planned to take assessments after childbirth
  • an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
  • to have good physical health judged by obstetricians.

Who cannot join

  • history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
  • Serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
  • difficult to expect a normal birth (ex: fetal malformation etc.)
  • having a history of bleeding disorder such as von Willebrand's Disease
  • regular treatment with aspirin or warfarin within the last 3 months
  • a smoking habit of ≥40 cigarettes per day
  • regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
  • a habit of eating fish as a main dish ≥4 times per week.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Japan3 sites

  • National Center for Child Health and Development

    Setagaya City, Tokyo

  • Tokyo Medical University

    Shinjyuku-ku, Tokyo, 160-8402

  • Toda Chuo Women's Hospital

    Toda, Saitama, 335-0022

Other trials in Japan

Taiwan1 site

  • China Medical University

    Taichung

Other trials in Taiwan

About this study

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

Read the 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. (Participants who skipped taking supplements for more than 7 days will be excluded from a per protocol analysis.)

Being tested
Omega-3 polyunsaturated fatty acids, Olive oil
Keywords
Pregnancy, Depression, omega-3 fatty acids
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 polyunsaturated fatty acidsDietary supplement

    Also called 1200mg EPA and 600mg DHA daily

  • Olive oilDietary supplement

    Also called 2880mg olive oil daily

Study groups in NCT02166424
Study groupRoleWhat they receive
Omega-3 polyunsaturated fatty acidsActive comparator1200mg eicosapentaenoic acid (EPA) and 600mg docosahexaenoic acid (DHA) daily
Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acids
olive oilPlacebo comparator2880mg olive oil daily
Receives: Dietary Supplement: Olive oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total score of the Hamilton Rating Scale for Depression (HAMD)

    Measured: Twelve weeks

Secondary outcomes (11)

  1. total score of HAMD

    Measured: 4-6 weeks after childbirth

  2. major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)

    Measured: Twelve weeks, 4-6 weeks after childbirth

  3. total scores on the Edinburgh Postnatal Depression Scale (EPDS)

    Measured: Twelve weeks, 4-6 weeks after childbirth

  4. total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)

    Measured: Twelve weeks, 4-6 weeks after childbirth

  5. omega-3 fatty acids concentrations in erythrocytes

    Measured: Tweve weeks, 4-6 weeks after childbirth

  6. brain-derived neurotrophic factor (BDNF) in serum

    Measured: Twelve weeks, 4-6 weeks after childbirth

  7. estrogen in plasma

    Measured: twelve weeks, 4-6 weeks after childbirth

  8. oxytocin in plasma

    Measured: twelve weeks, 4-6 weeks after childbirth

  9. progesterone in plasma

    Measured: twelve weeks, 4-6 weeks after childbirth

  10. human chorionic gonadotropin (hCG) in plasma

    Measured: twelve weeks, 4-6 weeks after childbirth

  11. phospholipase A2 in plasma

    Measured: twelve weeks, 4-6 weeks after childbirth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166424
Sponsor's protocol ID
SYNCHRO-RCT
Status last verified
Dec 2017
First submitted
15 Jun 2014
Last updated
21 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Nishi D, Su KP, Usuda K, Chiang YJ, Guu TW, Hamazaki K, Nakaya N, Sone T, Sano Y, Tachibana Y, Ito H, Isaka K, Hashimoto K, Hamazaki T, Matsuoka YJ. The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Sep 15;16(1):321. doi: 10.1186/s12888-016-1031-2.

    PubMed 27630014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega-3 polyunsaturated fatty acids and Olive oil in people with Pregnancy and Depression, run by Tokyo Medical University at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total score of the Hamilton Rating Scale for Depression (HAMD) (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.

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