How exercise affects the brain and inflammation in depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitario Príncipe de Asturias
  Alcalá de Henares, Madrid, Spain Recruiting
• Hospital Universitario Puerta de Hierro-Majadahonda
  Majadahonda, Madrid, Spain Recruiting
• Hospital Universitario de La Princesa
  Madrid, Spain Recruiting
• Hospital Universitario Ramón y Cajal
  Madrid, Spain Recruiting
• Hospital Universitario La Paz
  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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.