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NCT Number: NCT07462013

Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice

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).

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mind Body Interface Research Center (MBI Lab & Care)

Taichung, 404, Taiwan

Location status: Recruiting

Location contact

Kuan_Pin Su, MD, PhD

CONTACT

[email protected]

+886 (04) 2205-2121 ext. 14128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 50-80 years old
  • Major Depressive Disorder
  • Absence or mild cognitive impairment

Exclusion criteria

-

Treatment and study plan

Soybean oil (Standard treatment)

Dietary Supplement

3g/day of Soybean Oil

Eicosapentaenoic acid (omega-3 fatty acid)

Dietary Supplement

3 grams/day

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Gut microbiome composition

    Time frame: Weeks 0 and 24

    Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples.

  2. Fatty Acids Profiles in Blood

    Time frame: Weeks 0 and 24

    Fatty acid (FA) profiles in blood (red blood cells) are primarily measured using gas chromatography (GC).

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Collaborators

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli
  • University College Cork

Registry information

Official study title

Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)

Acronym: POWER

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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