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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario Príncipe de Asturias
RECRUITING
Alcalá De Henares
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro-Majadahonda
RECRUITING
Majadahonda
Contact Information
Primary
Javier Gómez Cumplido, PT, MSc
javier.gomezc@uam.es
(+34) 633467602
Backup
Pilar López García, PhD
p.lopez@uam.es
(+34) 91 497 54 48
Time Frame
Start Date: 2025-04-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 124
Treatments
Experimental: Exercise intervention group (EG)
Major Depressive Disorder patients will receive the exercise intervention for 12 weeks as an add-on to their usual treatment (antidepressant treatment prescribed by the attending specialist). They will gradually increase their levels of physical activity by daily walking and will conduct aerobic and muscle strength activities 2 days per week. The program will be supervised by a physical education and sports professional.
Active_comparator: Control group (CG)
Major Depressive Disorder patients will only receive standard treatment (antidepressant treatment prescribed by the attending specialist) and will be instructed to not change their usual physical activity.
Related Therapeutic Areas
Sponsors
Leads: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborators: Hospital Universitario La Paz, Quirón Madrid University Hospital, Hospital Universitario Ramon y Cajal, Hospital Universitario Principe de Asturias, Centro de Investigación Biomédica en Red de Salud Mental, Universidad Autonoma de Madrid, Hospital Universitario Puerta de Hierro de Majadahonda

This content was sourced from clinicaltrials.gov