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| Name | Class |
|---|---|
| IRCCS San Raffaele | OTHER |
| Istituto Neurologico Mediterraneo Neuromed S. R. L | OTHER |
| Azienda Sanitaria Locale di Pescara | OTHER |
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The goal of this clinical trial is to investigate the effect of a structured physical activity (PA) program on depressive symptomatology in adults with a diagnosis of major depression disorder (MDD). The study will evaluate changes in depressive symptoms and assess neurophysiological and biological modulations, including epigenetic, transcriptomic, and metabolic changes resulting from the PA intervention. The main questions it aims to answer are:
Participants will be randomized into two arms: the intervention group (n total=55), in treatment with antidepressants, participating in a 12-weeks PA program; the control group (n total=55), patients in treatment with antidepressants, without receiving the PA program.
All participants will be assessed at three-time points: T0 (baseline, before initiating the trial), T3 (after three months; at the end of the 12-week PA program), and T6 (6th-month follow up; three months after the PA completion).
At each assessment, all participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA-arm | Experimental | Participants assigned to the PA-arm will participate in at least three weekly 30-minute sessions of PA for a total of 12 weeks. |
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| Control-arm | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity (PA) program | Behavioral | Participants assigned to the PA-arm will participate in at least three weekly 30-minute sessions of PA for a total of 12 weeks. The PA program will be tailored to individuals' characteristics, skills and preferences, based on information collected in connection with the baseline assessment and physical examination. A PA program could preview some forms of aerobic/relaxation/anaerobic exercises |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome. | Baseline (day one), Month 3 (up to three months; end of treatment), Month 6 (up to 6 months; follow up). |
| Beck Depression Inventory - II | The Beck Depression Inventory (BDI) is a self-report questionnaire used to assess the presence and severity of depressive symptoms. It comprises 21 items, each rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome. | Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up) |
| Zung Self-Rating Depression Scale | The Zung Self-Rating Depression Scale (ZDS) is a self-administered questionnaire designed to assess the level of depressive symptoms in individuals. It consists of 20 items, each rated on a scale from 1 to 4, based on how often symptoms are experienced. The raw total score ranges from 20 to 80, which is often converted to an index score (ranging from 25 to 100) by multiplying the raw score by 1.25. Higher scores indicate more severe depression | Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up) |
| Personal and Social Performance Scale | The Personal and Social Performance Scale (PSP) is a clinician-rated instrument used to assess personal and social functioning in individuals with mental disorders. The total score ranges from 1 to 100, with higher scores indicating better functioning and a more favorable clinical outcome. | Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up) |
| Measure | Description | Time Frame |
|---|---|---|
| EEG-derived neurophysiological metrics, including spectral, coherence, source localization, and graph-based connectivity measures | Electroencephalogram (EEG) recordings will be used to derive (a) Individual spectral analysis (theta/alpha transition frequency and individual alpha frequency); (b) Analysis of coherence; c) EEG source localisation with low resolution brain electromagnetic tomograghy; d) Analysis of connectivity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro San Giovanni fi Dio Fatebenefratelli | Brescia | 25125 | Italy | |||
| Istituto Neurologico Mediterraneo Neuromed, NEUROMED |
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Two-arm randomized controlled design
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| World Health Organization Quality of Life - Bref | The WHOQOL-BREF is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome. | Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up) |
| Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up) |
| Metabolic analyses | Plasma/serum levels of glucose and lipid metabolism markers | Baseline (Day 1); Month 3 (up to 3 months; end of treatment) |
| Motor activity and circadian/sleep profiles | Total activity count for every active minute throughout the day wearing an Actigraph accelerometer. | 24h/day for 7 days before baseline, months 3 (at the end of the trial) and month 6 (up to 6 months follow up) |
| Differentially Expressed genes and biological pathways modulation | Baseline (Day 1); Month 3 (up to 3 months; end of treatment) |
| DNA Methylation | Baseline (Day 1); Month 3 (up to 3 months; end of treatment) |
| Isernia |
| 86077 |
| Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Sanitaria Locale di Pescara | Pescara | 65124 | Italy |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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