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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorNational Science and Technology Council, Taiwan

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 50-80 years old

Major Depressive Disorder

Absence or mild cognitive impairment

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Soybean oil (Standard treatment)

    Dietary supplement

    3g/day of Soybean Oil

  • Eicosapentaenoic acid (omega-3 fatty acid)

    Dietary supplement

    3 grams/day

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Eicosapentaenoic Acid (EPA)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Weeks 0, 4, 8, 12, 16, 24
2

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.

Time frame
Weeks 0, 4, 8, 12, 16, 24
3

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.

Time frame
Weeks 0, 4, 8, 12, 16, 24
4

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.

Time frame
Weeks 0, 4, 8, 12, 16, 24

Secondary outcomes

1

Gut microbiome composition

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

Time frame
Weeks 0 and 24
2

Fatty Acids Profiles in Blood

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

Time frame
Weeks 0 and 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Science and Technology Council, Taiwan

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Collaborator

University College Cork

Collaborator