Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06450704

Inflammatory and Brain Mechanisms and Clinical and Cognitive Effects of an Exercise Intervention in Major Depressive Disorder: a Randomised Longitudinal Clinical Trial.

Led by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Updated on 2026-01-06

124

Participants Needed

5

Research Sites

17 weeks

Total Duration

On this page

Sponsors

F

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Lead Sponsor

H

Hospital Universitario La Paz

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how physical exercise affects patients with Major Depressive Disorder (MDD), focusing on the anti-inflammatory, oxidative stress, and brain mechanisms behind the antidepressant effects of exercise. This trial aims to understand how effective a physical exercise program is when combined with standard antidepressant treatment in real-life conditions. The study also explores improvements in depressive symptoms, cognitive performance, functioning, and well-being over time. The trial randomly assigns participants to one of two groups: an exercise intervention group that receives a 12-week physical exercise program alongside their usual antidepressant medication, and a control group that continues only their standard antidepressant treatment without changing their physical activity. The exercise program includes daily walking monitored with an activity band and twice-weekly supervised online aerobic and strength sessions using elastic bands and body weight exercises, progressing in intensity and difficulty. Participants will be assessed at three time points: before starting the intervention, after 12 weeks, and one year later. Researchers will measure inflammatory and oxidative stress biomarkers, brain imaging changes, clinical evaluations, cognitive function, physical fitness, activity behaviors, and well-being. Monitoring includes use of wearable devices for step counting and activity tracking, and the study evaluates long-term effects and patient acceptance of the exercise program.

CONDITIONS

Brief Title

Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria confirmed by Mini International Neuropsychiatric Interview (MINI)
  • Moderate depression severity with a minimum score of 14 on the Hamilton Depression Rating Scale 17 items (HAM-D17)
  • Receiving outpatient clinical care
  • Currently on antidepressant treatment that will be maintained during the 12-week exercise intervention
Not Eligible

You will not qualify if you...

  • Diagnosis of any axis I psychiatric disorder other than Major Depressive Disorder
  • Contraindications for Magnetic Resonance Imaging
  • Use of antiinflammatory treatments or antibiotics within the week before randomization
  • Vaccination within the month before randomization
  • Fever over 38ºC at study entry
  • Pregnancy
  • Alcohol or drug abuse

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Treatment

Duration - 12 weeks

Participants receive a 12-week intervention period where those in the exercise group add a physical exercise program to their standard antidepressant treatment, including daily walking monitored by an activity band and supervised aerobic and strength exercise sessions twice per week. Participants in the control group continue their standard antidepressant treatment without changing their physical activity.

Twice weekly supervised online exercise sessions and daily activity monitoring for 12 weeks; assessments at baseline and after 12 weeks

Follow-up

Duration - Approximately 9 months after treatment ends (1 year total from randomization)

Participants are followed for 1 year after randomization to assess the long-term effects of the intervention on clinical, cognitive, and biological outcomes.

Assessments at 1 year post-randomization

Trial Site Locations

Total: 5 locations

1

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain, 28805

Actively Recruiting

2

Hospital Universitario de La Princesa

Madrid, Madrid, Spain, 28006

Actively Recruiting

3

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain, 28034

Actively Recruiting

4

Hospital Universitario La Paz

Madrid, Madrid, Spain, 28046

Actively Recruiting

5

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain, 28222

Actively Recruiting

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Research Team

J

Javier Gómez Cumplido, PT, MSc

P

Pilar López García, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 5. Complementary and Alternative Medicine Treatments.

Arun V Ravindran, Lynda G Balneaves, Guy Faulkner...

https://pubmed.ncbi.nlm.nih.gov/27486153

Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report.

A John Rush, Madhukar H Trivedi, Stephen R Wisniewski...

https://pubmed.ncbi.nlm.nih.gov/17074942