Major Depressive DisorderNCT03871088
N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
A study testing Omega-3 fatty acids in people with Major Depressive Disorder, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial summary
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2015to Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the diagnostic criteria of DSM-IV for MDD
- 18 to 65 years old
- pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD)
- physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests
- have not received any psychiatric treatment in 2 weeks
- competent to receive a full explanation of this study and give written informed consent.
Who cannot join
- a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders
- AxisII diagnoses, including borderline and antisocial personality disorder
- a notable medical comorbidity
- acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary
- regular consumption of omega-3 PUFAs supplements or a habit of eating fish equal or more than 4 times per week
Trial locations and contacts
1 site in 1 country.
About this study
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.
Read the detailed description
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.
- Conditions
- Major Depressive Disorder
- Being tested
- Omega-3 fatty acids
- Keywords
- Depression, omega-3 fatty acids, nutritional intervention
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDietary supplement
12-week double-blind, randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| Eicosapentaenoic acid (EPA) | Active comparator | Eicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3). Receives: Dietary Supplement: Omega-3 fatty acids |
| Docosahexaenoic acid (DHA) | Experimental | Docosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3). Receives: Dietary Supplement: Omega-3 fatty acids |
| EPA/DHA combination | Active comparator | EPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids. Receives: Dietary Supplement: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAMD) Changes
The Changes of scores in Hamilton Rating Scale for Depression
Measured: From Week 0 to Week 12
Secondary outcomes (2)
Response rate
50% decreases in the Hamilton Rating Scale for Depression from W0 to W12
Measured: at Week 12
Remission rate
Less than 8 points in the Hamilton Rating Scale for Depression at W12
Measured: at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study startJul 2015
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871088
- Sponsor's protocol ID
- NHRI-EX105-10528NI
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
- ClinicalTrials.gov ID
- NCT03871088
- Acronym / sponsor ID
- NHRI-EX105-10528NI
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, omega-3 fatty acids, nutritional intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Mar 2019 (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.
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.
Detailed description
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eicosapentaenoic acid (EPA) | Active comparator | Dietary Supplement: Omega-3 fatty acidsEicosapentaenoic acid (EPA) is an omega-3 fatty acid. In physiological literature, it is given the name 20:5(n-3). |
| Docosahexaenoic acid (DHA) | Experimental | Dietary Supplement: Omega-3 fatty acidsDocosahexaenoic acid (DHA) is an omega-3 fatty acid. In physiological literature, it is given the name 22:6(n-3). |
| EPA/DHA combination | Active comparator | Dietary Supplement: Omega-3 fatty acidsEPA/DHA means the combination of omega-3 fatty acids Eicosapentaenoic and Docosahexaenoic acids. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the diagnostic criteria of DSM-IV for MDD
- 18 to 65 years old
- pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD)
- physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests
- have not received any psychiatric treatment in 2 weeks
Key exclusion criteria (5 listed)
- a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders
- AxisII diagnoses, including borderline and antisocial personality disorder
- a notable medical comorbidity
- acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary
- regular consumption of omega-3 PUFAs supplements or a habit of eating fish equal or more than 4 times per week
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 fatty acids12-week double-blind, randomized controlled trial | Dietary supplement | Docosahexaenoic acid (DHA), EPA/DHA combination, Eicosapentaenoic acid (EPA) |
Primary outcome
Hamilton Rating Scale for Depression (HAMD) Changes
Time frame: From Week 0 to Week 12
The Changes of scores in Hamilton Rating Scale for Depression
2 secondary outcomes
Response rate
Time frame: at Week 12
Remission rate
Time frame: at Week 12
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 12 Mar 2019.
- Individual participant dataSharing planned: No
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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 fatty acids in people with Major Depressive Disorder, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
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 5 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 12 Mar 2019. 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 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. 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?
Hamilton Rating Scale for Depression (HAMD) Changes (time frame: From Week 0 to Week 12). 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 12 Mar 2019.