Exercise as an Add-On Treatment for Depression
Tests whether an exercise program added to usual antidepressants helps adults with major depression.
Plain-language title generated from the registry record
Registry title: Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
Key facts
- Where
- Alcalá de Henares, Madrid, and Majadahonda, SpainSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06450704, who can take part
Where in Spain
- Hospital Universitario Principe de AsturiasAlcalá de Henares, SpainTaking people
- Hospital Universitario de la PrincesaMadrid, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Puerta de Hierro - MajadahondaMajadahonda, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Trial code
- NCT06450704
- Record updated
- 2 September 2026
- Original description
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:Read full original descriptionShow less
Inflammatory and Brain Mechanisms and Clinical and Cognitive Effects of an Exercise Intervention in Major Depressive Disorder: a Randomised Longitudinal Clinical 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.
Inclusion: 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: Antiinflammatory treatments or antibiotics within the week before randomisation; Vaccines within the month before randomisation; Alcohol or drug abuse; Diagnosis of any axis I diagnosis except for MDD; Contraindications for Magnetic Resonance Imaging; Fever (>38ºC) at the moment of study entry; Pregnant women.