RecruitingNot ApplicableNCT06450704

Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders

Inflammatory and Brain Mechanisms and Clinical and Cognitive Effects of an Exercise Intervention in Major Depressive Disorder: a Randomised Longitudinal Clinical Trial.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Enrollment

124 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Inflammatory Response Major Depressive Disorder

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 to see if a physical exercise intervention would induce a significant improvement in depressive symptoms and which mechanisms are responsible for this result.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how exercise affects the brain and inflammation in people with moderate-to-severe major depression. Participants will undergo 12 weeks of structured physical exercise while researchers track brain imaging, blood markers, and mood scores. **You may be eligible if...** - You have a diagnosis of major depressive disorder (MDD) meeting DSM-5 criteria - Your depression is at least moderate severity (HAM-D17 score ≥14) - You are currently receiving outpatient care and taking antidepressants (which you will continue during the study) **You may NOT be eligible if...** - You have any other psychiatric diagnosis besides MDD - You have contraindications to MRI - You took anti-inflammatory medications or antibiotics within a week before enrolling - You received a vaccine within the month before enrolling Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPhysical Exercise

Daily walking. Participants will be given an activity band to self-monitor the number of steps they walk each day during the 12-week intervention period. Each participant must reach a certain number of daily steps with a progressive goal adjusted to the number of steps from the previous week. The goal is set considering the superior number to the median of steps of the preceding week. Weekly combined exercise sessions (aerobic + strength exercise) 2 sessions of 60 minutes per week in a 12-week program. The exercise intervention will combine the use of elastic bands and the body weight. First, 5 minutes of warm-up; second, training circuit with low-intensity strength exercises alternating work and rest times using rhythmic music. Upper, lower and middle body exercises will alternate. The program will progress in intensity, work: rest ratio, and technical difficulty of the exercises. At the end of the main part, there will be a cool-down and stretching for 5 minutes.

DRUGAntidepressant medication (ADM)

Patients will receive their standard antidepressant treatment prescribed by their psychiatrist.