NCT06450704Recruiting
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.
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 5 Jun 2024
- Start date
- 21 Apr 2025
- Primary completion date
- 31 May 2028
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Diseases
- Depression
- NCT number
- NCT06450704
What you commit to
- Study type: Interventional
- Planned participants: 124
- From 21 Apr 2025 to the primary completion date, 31 May 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antiinflammatory treatments or antibiotics within the week before randomisation.
- Vaccines within the month before randomisation.
- Alcohol or drug abuse.
Other
- Diagnosis of any axis I diagnosis except for MDD;
- Contraindications for Magnetic Resonance Imaging.
- Fever (\>38ºC) at the moment of study entry.
- Pregnant women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Principe de Asturias Coordinator of this site? Confirm its status | Alcalá de Henares | Spain | Recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.