Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disord
The goal of this clinical trial is to study how physical exercise works when applied to patients diagnosed with Major Depressive Disorder (MDD). The main questions it aims to answer are: * What are the antiinflammatory and oxidative stress and neural mechanisms involved in the antidepressant effects of exercise? * How
| Condition(s) | Major Depressive Disorder, Inflammatory Response |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to study how physical exercise works when applied to patients diagnosed with Major Depressive Disorder (MDD). The main questions it aims to answer are: * What are the antiinflammatory and oxidative stress and neural mechanisms involved in the antidepressant effects of exercise? * How effective is a physical exercise program in MDD patients in real-life conditions? The experimental group will receive an exercise intervention as an add-on to their usual treatment (antidepressant treatment prescribed by the attending specialist). Researchers will compare to a control group, which will only receive standard treatment (antidepressant treatment prescribed by the attending specialist) and will be instructed to not change their usual physical activity. The aim is |
| Who can participate | Inclusion Criteria: * A diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria (through the Mini International Neuropsychiatric Interview (MINI) * Severity of depression according to the Hamilton Depression Rating Scale 17 items (HAM-D17): minimum of 14 cut-off score of moderate depression. * Outpatient clinical care. * Current antidepressant treatment that will be maintained during the 12 weeks of the physical exercise intervention. Exclusion Criteria: * Diagnosis of any axis I diagnosis except for MDD; * Contraindications for Magnetic Resonance Imaging. * Antiinflammatory treatments or antibiotics within the week before randomisation. * Vaccines within the month before randomisation. * Fever (\>38ºC) at the moment of study entry. * Pregnant women. * Alcohol or drug abus |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
| Locations | Alcalá de Henares, Madrid, Spain; Madrid, Madrid, Spain; Madrid, Madrid, Spain; Madrid, Madrid, Spain; Majadahonda, Madrid, Spain |
| Start date | 2025-04-21 |
| NCT ID | NCT06450704 |
| Official listing | https://clinicaltrials.gov/study/NCT06450704 |