Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06450704

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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