Depressive SymptomsNCT07013981
The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)in Tokyo: Open Trial
A study testing Omega-3 polyunsaturated fatty acids in people with Depressive Symptoms, run by National Science and Technology Council, Taiwan at 1 site in Japan.
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 to 50 years, women only
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Omega-3 polyunsaturated fatty acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteJapan
- Study dates
- 9 Jan 2013to 11 Nov 2017
- Phase
- Interventional
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women aged 20 years or older.
- between 12-24 weeks gestation.
- a Japanese conversational ability to understand the scope of the present trial.
- planned to return to the hospital for checkup at 4-6 weeks 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.
- the item of EPDS concerning suicide ideation is 2 or more.
- other 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.
Show all 9Show fewer
- 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 ≥4 times per week.
Trial locations and contacts
1 site in 1 country.
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.
- Conditions
- Depressive Symptoms
- Being tested
- Omega-3 polyunsaturated 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
Omega-3 polyunsaturated fatty acidsDietary supplement
Also called 320 mg olive oil and 9.9 mg omega-3 PUFAs
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 polyunsaturated fatty acids | Experimental | 1200mg EPA and 600mg DHA daily Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acids |
| Placebo Comparator | Placebo comparator | 320 mg olive oil and 9.9 mg omega-3 PUFAs Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of the Hamilton Rating Scale for Depression(HAMD)
The Hamilton Rating Scale for Depression (HAMD) is a commonly used clinical tool for assessing the severity of depression. The most frequently used version, the HAMD-17, includes 17 items and has a total score range from 0 to 52. Higher scores indicate more severe depressive symptoms and thus a worse outcome, while lower scores suggest milder symptoms or improvement.
Measured: Twelve weeks
Secondary outcomes (11)
Total score of the Hamilton Rating Scale for Depression(HAMD)
The Hamilton Rating Scale for Depression (HAMD) is a commonly used clinical tool for assessing the severity of depression. The most frequently used version, the HAMD-17, includes 17 items and has a total score range from 0 to 52. Higher scores indicate more severe depressive symptoms and thus a worse outcome, while lower scores suggest milder symptoms or improvement.
Measured: 4-6 weeks after childbirth
Total scores on the Edinburgh Postnatal Depression Scale(EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a screening tool used to identify symptoms of postpartum depression. It consists of 10 items, each scored from 0 to 3, giving a minimum total score of 0 and a maximum total score of 30. Higher scores indicate more severe depressive symptoms, meaning a worse outcome, while lower scores suggest fewer or milder symptoms.
Measured: Twelve weeks, 4-6 weeks after childbirth
Total score of the Beck Depression Inventory II (BDI-II)
The Beck Depression Inventory-II (BDI-II) is a widely used self-report questionnaire designed to assess the severity of depressive symptoms. It includes 21 items, each scored from 0 to 3, resulting in a minimum total score of 0 and a maximum total score of 63. Higher scores indicate more severe depression, meaning a worse outcome, while lower scores reflect fewer or less severe symptoms.
Measured: Twelve weeks, 4-6 weeks after childbirth
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
Omega-3 fatty acids concentrations in erythrocytes
Measured: Twelve weeks, 4-6 weeks after childbirth
Brain-derived neurotrophic factor(BDNF)in serum
Measured: Twelve weeks, 4-6 weeks after childbirth
Estrogen in serum
Measured: Twelve weeks, 4-6 weeks after childbirth
Oxytocin in serum
Measured: Twelve weeks, 4-6 weeks after childbirth
Progesterone in serum
Measured: Twelve weeks, 4-6 weeks after childbirth
Human chorionic gonadotropin (hCG)in serum
Measured: Twelve weeks, 4-6 weeks after childbirth
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.
- First posted10 Jun 2025
- Study start9 Jan 2013
- Primary completion11 May 2017
- Study completion11 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Collaborators
- Japanese Society for the Promotion of Science, University of Toyama, Chiba University
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013981
- Sponsor's protocol ID
- CMUH102-REC1-060
- Status last verified
- Jun 2025
- First submitted
- 7 Oct 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)in Tokyo: Open Trial
- ClinicalTrials.gov ID
- NCT07013981
- Acronym / sponsor ID
- CMUH102-REC1-060
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Collaborators
- Japanese Society for the Promotion of Science, University of Toyama, Chiba University
- Study start
- 9 Jan 2013 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 polyunsaturated fatty acids | Experimental | Dietary Supplement: Omega-3 polyunsaturated fatty acids1200mg EPA and 600mg DHA daily |
| Placebo Comparator | Placebo comparator | Dietary Supplement: Omega-3 polyunsaturated fatty acids320 mg olive oil and 9.9 mg omega-3 PUFAs |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- pregnant women aged 20 years or older.
- between 12-24 weeks gestation.
- a Japanese conversational ability to understand the scope of the present trial.
- planned to return to the hospital for checkup at 4-6 weeks after childbirth.
- an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more.
Key exclusion criteria (9 listed)
- history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder.
- the item of EPDS concerning suicide ideation is 2 or more.
- other 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 polyunsaturated fatty acidsAlso: 1200mg EPA and 600mg DHA daily | Dietary supplement | Omega-3 polyunsaturated fatty acids |
| Omega-3 polyunsaturated fatty acidsAlso: 320 mg olive oil and 9.9 mg omega-3 PUFAs | Dietary supplement | Placebo Comparator |
Primary outcome
Total score of the Hamilton Rating Scale for Depression(HAMD)
Time frame: Twelve weeks
The Hamilton Rating Scale for Depression (HAMD) is a commonly used clinical tool for assessing the severity of depression. The most frequently used version, the HAMD-17, includes 17 items and has a total score range from 0 to 52. Higher scores indicate more severe depressive symptoms and thus a worse outcome, while lower scores suggest milder symptoms or improvement.
11 secondary outcomes
Total score of the Hamilton Rating Scale for Depression(HAMD)
Time frame: 4-6 weeks after childbirth
Total scores on the Edinburgh Postnatal Depression Scale(EPDS)
Time frame: 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
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
Omega-3 fatty acids concentrations in erythrocytes
Time frame: Twelve weeks, 4-6 weeks after childbirth
Brain-derived neurotrophic factor(BDNF)in serum
Time frame: Twelve weeks, 4-6 weeks after childbirth
Estrogen in serum
Time frame: Twelve weeks, 4-6 weeks after childbirth
Oxytocin in serum
Time frame: Twelve weeks, 4-6 weeks after childbirth
Progesterone in serum
Time frame: Twelve weeks, 4-6 weeks after childbirth
Human chorionic gonadotropin (hCG)in serum
Time frame: Twelve weeks, 4-6 weeks after childbirth
Phospholipase A2 in plasma
Time frame: twelve weeks, 4-6 weeks after childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 polyunsaturated fatty acids in people with Depressive Symptoms, run by National Science and Technology Council, Taiwan at 1 site in Japan.
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 9 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 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
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?
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 10 Jun 2025.