Major Depressive Disorder (MDD)
Conditions
Brief 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 frequently co-occur in individuals with Major Depressive Disorder (MDD).
Interventions
3g/day of Soybean Oil
3 grams/day
Sponsors
Study design
Intervention 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)).
Eligibility
Inclusion criteria
* Aged 50-80 years old * Major Depressive Disorder * Absence or mild cognitive impairment
Exclusion criteria
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Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 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. |
| Executive Functioning | 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. |
| General Cognitive Ability and Memory & Attention | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition | Weeks 0 and 24 | Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples. |
| Fatty Acids Profiles in Blood | Weeks 0 and 24 | Fatty acid (FA) profiles in blood (red blood cells) are primarily measured using gas chromatography (GC). |
Countries
Taiwan