How exercise affects the brain and inflammation in depression
Inflammatory and Brain Mechanisms and Clinical and Cognitive Effects of an Exercise Intervention in Major Depressive Disorder: a Randomised Longitudinal Clinical Trial.
This project tests whether adding a structured exercise program to standard antidepressant treatment helps people with moderate major depressive disorder and whether it reduces inflammation and changes brain markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Locations | 5 sites (Alcalá de Henares, Madrid and 4 other locations) |
| Trial ID | NCT06450704 on ClinicalTrials.gov |
What this trial studies
Outpatients with moderate Major Depressive Disorder who are on stable antidepressant medication will be assigned to either a 12-week structured physical exercise program added to their usual care or to continue usual care without changing activity. Depressive symptoms will be measured with the HAM-D17, while blood samples will be taken to measure inflammatory and oxidative stress markers and MRI scans will probe brain structure and function before and after the intervention. The study aims to connect clinical changes in mood with shifts in inflammatory signaling, oxidative stress, and neuroimaging findings to clarify mechanisms. The exercise program is delivered in routine outpatient settings to test both effectiveness and real-world feasibility as an add-on to pharmacologic treatment.
Who should consider this trial
Good fit: Adults with a DSM-5 diagnosis of Major Depressive Disorder, outpatient care, HAM-D17 score of at least 14, on a stable antidepressant regimen, able to undergo MRI and participate in exercise.
Not a fit: People who are pregnant, have other axis I diagnoses, recent antiinflammatory treatment or vaccines, fever, MRI contraindications, substance abuse, or who cannot safely perform exercise are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce depressive symptoms as an affordable add-on to medication and identify biological markers that explain who benefits most.
How similar studies have performed: Previous trials have shown that exercise can improve mild-to-moderate depression, but mechanistic links to inflammation and brain imaging remain under-studied and are the novel focus here.
Eligibility criteria
Show full inclusion / exclusion criteria
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 abuse.
Where this trial is running
Alcalá de Henares, Madrid and 4 other locations
- Hospital Universitario Príncipe de Asturias — Alcalá de Henares, Madrid, Spain (Recruiting)
- Hospital Universitario de La Princesa — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro-Majadahonda — Majadahonda, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Pilar López García, PhD — Universidad Autonoma de Madrid
- Study coordinator: Javier Gómez Cumplido, PT, MSc
- Email: javier.gomezc@uam.es
- Phone: (+34) 633467602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.