NCT06450704 Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
| NCT ID | NCT06450704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2025-04-21 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Pilar López García, PhD
PRINCIPAL INVESTIGATOR
Universidad Autonoma de Madrid
Frequently Asked Questions
Who can join the NCT06450704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06450704 currently recruiting?
Yes, NCT06450704 is actively recruiting participants. Contact the research team at javier.gomezc@uam.es for enrollment information.
Where is the NCT06450704 trial being conducted?
This trial is being conducted at Alcalá de Henares, Spain, Madrid, Spain, Madrid, Spain, Madrid, Spain and 1 additional location.
Who is sponsoring the NCT06450704 clinical trial?
NCT06450704 is sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. The principal investigator is Pilar López García, PhD at Universidad Autonoma de Madrid. The trial plans to enroll 124 participants.