Actively Recruiting
Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
Led by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Updated on 2026-01-06
124
Participants Needed
5
Research Sites
88 weeks
Total Duration
On this page
Sponsors
F
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead Sponsor
H
Hospital Universitario La Paz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 to see if a physical exercise intervention would induce a significant improvement in depressive symptoms and which mechanisms are responsible for this result.
CONDITIONS
Official Title
Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria confirmed by Mini International Neuropsychiatric Interview (MINI)
- Moderate depression with a Hamilton Depression Rating Scale 17 items (HAM-D17) score of 14 or higher
- Receiving outpatient clinical care
- Current antidepressant treatment maintained during the 12-week exercise intervention
You will not qualify if you...
- Diagnosis of any axis I disorder other than Major Depressive Disorder
- Contraindications for Magnetic Resonance Imaging (MRI)
- Use of anti-inflammatory treatments or antibiotics within one week before randomization
- Vaccination within one month before randomization
- Fever above 38ºC at study entry
- Pregnancy
- Alcohol or drug abuse
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Actively Recruiting
2
Hospital Universitario de La Princesa
Madrid, Madrid, Spain, 28006
Actively Recruiting
3
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
4
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
5
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
Research Team
J
Javier Gómez Cumplido, PT, MSc
CONTACT
P
Pilar López García, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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