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| Name | Class |
|---|---|
| IRCCS Centro San Giovanni di Dio Fatebenefratelli | OTHER |
| University College Cork | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eicosapentaenoic Acid (EPA) | Experimental | 3 gram/day |
|
| Placebo | Placebo Comparator | Soy Bean Oil, 3 gram/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soybean oil (Standard treatment) | Dietary Supplement | 3g/day of Soybean Oil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Weeks 0, 4, 8, 12, 16, 24 |
| Depressive Symptoms | The Montgomery-Ã…sberg 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome composition | Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mind Body Interface Research Center (MBI Lab & Care) | Recruiting | Taichung | Taichung | 404 | Taiwan |
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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)).
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| Eicosapentaenoic acid (omega-3 fatty acid) |
| Dietary Supplement |
3 grams/day |
|
| 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. | 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. | 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. | Weeks 0, 4, 12, 24 |
| Weeks 0 and 24 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013024 | Soybean Oil |
| D015118 | Eicosapentaenoic Acid |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
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