Major Depressive Disorder (MDD)POWERNCT07462013
Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice
A study testing Soybean oil (Standard treatment) and Eicosapentaenoic acid (omega-3 fatty acid) in people with Major Depressive Disorder (MDD), run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial summary
POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Soybean oil (Standard treatment) and Eicosapentaenoic acid (omega-3 fatty acid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50-80 years old
- Major Depressive Disorder
- Absence or mild cognitive impairment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Mind Body Interface Research Center (MBI Lab & Care)
Taichung, Taichung, 404
Kuan_Pin Su, MD, PhD, +886 (04) 2205-2121 ext. 14128, cobol@cmu.edu.tw
About this study
Official title: Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)
POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that frequently co-occur in individuals with Major Depressive Disorder (MDD).
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Soybean oil (Standard treatment), Eicosapentaenoic acid (omega-3 fatty acid)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean oil (Standard treatment)Dietary supplement
3g/day of Soybean Oil
Eicosapentaenoic acid (omega-3 fatty acid)Dietary supplement
3 grams/day
| Study group | Role | What they receive |
|---|---|---|
| Eicosapentaenoic Acid (EPA) | Experimental | 3 gram/day Receives: Dietary Supplement: Eicosapentaenoic acid (omega-3 fatty acid) |
| Placebo | Placebo comparator | Soy Bean Oil, 3 gram/day Receives: Dietary Supplement: Soybean oil (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
The 17-item version (HAMD-17) is used to quantify the severity of depression. A score of ≥18 shows a significant depression level.
Measured: Weeks 0, 4, 8, 12, 16, 24
Depressive Symptoms
The GDS-15 (15-item Geriatric Depression Scale), a score of 5 or higher (≥5) indicates the presence of depression, or "clinically relevant" depressive symptoms.
Measured: Weeks 0, 4, 8, 12, 16, 24
Depressive Symptoms
The 20-item Center for Epidemiological Studies Depression Scale (CES-D) to indicate significant, or "clinical," depressive symptoms is a total score higher than or equal to 16.
Measured: Weeks 0, 4, 8, 12, 16, 24
Depressive Symptoms
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale with a total score range of 0 to 60, where higher scores indicate more severe depression.
Measured: Weeks 0, 4, 8, 12, 16, 24
Executive Functioning
The Trail Making Test (TMT) evaluates cognitive impairment by measuring the time (in seconds) to complete tasks. Higher scores indicate slower, more impaired performance.
Measured: Weeks 0, 4, 12, 24
Executive Functioning
Based on clinical literature, the Reliable Digit Span (RDS)-a raw score sum of the longest string of digits recalled forward and backward-is a common embedded measure of executive functioning and performance validity. Below 7 indicates a need for caution regarding the validity of the patient's cognitive effort or indicates a potential decline in working memory/attention.
Measured: Weeks 0, 4, 12, 24
Executive Functioning
The Modified Wisconsin Card Sorting Test (M-WCST) assesses executive functioning, with higher scores indicating greater dysfunction or impairment.
Measured: Weeks 0, 4, 12, 24
General Cognitive Ability and Memory & Attention
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses age-corrected index scores (Mean=100, SD=15) to identify cognitive impairment. Cutoff points for identifying impairment are set at 1 or 1.5 standard deviations (SD) below the mean.
Measured: Weeks 0, 4, 12, 24
Processing Speed
Commonly used cut-off points for identifying cognitive impairment using the Digit Symbol Substitution Test (DSST) often fall within the range of lower than or equal to 25-35 points.
Measured: Weeks 0, 4, 12, 24
Secondary outcomes (2)
Gut microbiome composition
Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples.
Measured: Weeks 0 and 24
Fatty Acids Profiles in Blood
Fatty acid (FA) profiles in blood (red blood cells) are primarily measured using gas chromatography (GC).
Measured: Weeks 0 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Oct 2025
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Model description
- Participants will be randomly assigned to one of two groups: 1) soybean oil placebo, 2) omega-3 PUFA supplementation (3g/day of eicosapentaenoic acid (EPA)).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Collaborators
- IRCCS Centro San Giovanni di Dio Fatebenefratelli, University College Cork
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462013
- Sponsor's protocol ID
- CMUH114-REC3-136
- Acronym
- POWER
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)
- ClinicalTrials.gov ID
- NCT07462013
- Acronym / sponsor ID
- POWER / CMUH114-REC3-136
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Collaborators
- IRCCS Centro San Giovanni di Dio Fatebenefratelli, University College Cork
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 Mar 2026 (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.
POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that frequently co-occur in individuals with Major Depressive Disorder (MDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: 1) soybean oil placebo, 2) omega-3 PUFA supplementation (3g/day of eicosapentaenoic acid (EPA)).
| Arm | Type | Receives |
|---|---|---|
| Eicosapentaenoic Acid (EPA) | Experimental | Dietary Supplement: Eicosapentaenoic acid (omega-3 fatty acid)3 gram/day |
| Placebo | Placebo comparator | Dietary Supplement: Soybean oil (Standard treatment)Soy Bean Oil, 3 gram/day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 50-80 years old
- Major Depressive Disorder
- Absence or mild cognitive impairment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Soybean oil (Standard treatment)3g/day of Soybean Oil | Dietary supplement | Placebo |
| Eicosapentaenoic acid (omega-3 fatty acid)3 grams/day | Dietary supplement | Eicosapentaenoic Acid (EPA) |
Primary outcome
Depressive Symptoms
Time frame: Weeks 0, 4, 8, 12, 16, 24
The 17-item version (HAMD-17) is used to quantify the severity of depression. A score of ≥18 shows a significant depression level.
Depressive Symptoms
Time frame: Weeks 0, 4, 8, 12, 16, 24
The GDS-15 (15-item Geriatric Depression Scale), a score of 5 or higher (≥5) indicates the presence of depression, or "clinically relevant" depressive symptoms.
Depressive Symptoms
Time frame: Weeks 0, 4, 8, 12, 16, 24
The 20-item Center for Epidemiological Studies Depression Scale (CES-D) to indicate significant, or "clinical," depressive symptoms is a total score higher than or equal to 16.
Depressive Symptoms
Time frame: Weeks 0, 4, 8, 12, 16, 24
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale with a total score range of 0 to 60, where higher scores indicate more severe depression.
Executive Functioning
Time frame: Weeks 0, 4, 12, 24
The Trail Making Test (TMT) evaluates cognitive impairment by measuring the time (in seconds) to complete tasks. Higher scores indicate slower, more impaired performance.
Executive Functioning
Time frame: Weeks 0, 4, 12, 24
Based on clinical literature, the Reliable Digit Span (RDS)-a raw score sum of the longest string of digits recalled forward and backward-is a common embedded measure of executive functioning and performance validity. Below 7 indicates a need for caution regarding the validity of the patient's cognitive effort or indicates a potential decline in working memory/attention.
Executive Functioning
Time frame: Weeks 0, 4, 12, 24
The Modified Wisconsin Card Sorting Test (M-WCST) assesses executive functioning, with higher scores indicating greater dysfunction or impairment.
General Cognitive Ability and Memory & Attention
Time frame: Weeks 0, 4, 12, 24
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses age-corrected index scores (Mean=100, SD=15) to identify cognitive impairment. Cutoff points for identifying impairment are set at 1 or 1.5 standard deviations (SD) below the mean.
Processing Speed
Time frame: Weeks 0, 4, 12, 24
Commonly used cut-off points for identifying cognitive impairment using the Digit Symbol Substitution Test (DSST) often fall within the range of lower than or equal to 25-35 points.
2 secondary outcomes
Gut microbiome composition
Time frame: Weeks 0 and 24
Fatty Acids Profiles in Blood
Time frame: Weeks 0 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soybean oil (Standard treatment) and Eicosapentaenoic acid (omega-3 fatty acid) in people with Major Depressive Disorder (MDD), 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: Weeks 0, 4, 8, 12, 16, 24). The study lists 9 primary outcomes in all. 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 17 Jun 2026.