Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
Recruiting · NCT06450704 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Fever (\>38ºC) at the moment of study entry.
- Pregnant women.
- Alcohol or drug abuse.
Where it is running
5 locations listed.
- Hospital Universitario de La Princesa - Madrid, Spain
- Hospital Universitario Ramón y Cajal - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Hospital Universitario Príncipe de Asturias - Alcalá de Henares, Madrid, Spain
- Hospital Universitario Puerta de Hierro-Majadahonda - Majadahonda, Madrid, Spain