About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Physical Exercise
- Antidepressant medication (ADM)
Treatment groups
Sponsors and collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead sponsor
Hospital Universitario La Paz
Collaborator
Hospital Universitario Ramon y Cajal
Collaborator
Hospital Universitario Principe de Asturias
Collaborator
Quirón Madrid University Hospital
Collaborator
Universidad Autonoma de Madrid
Collaborator
Centro de Investigación Biomédica en Red de Salud Mental
Collaborator
Puerta de Hierro University Hospital
Collaborator