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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Physical Exercise
  • Antidepressant medication (ADM)

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Lead sponsor

Hospital Universitario La Paz

Collaborator

Hospital Universitario Ramon y Cajal

Collaborator

Hospital Universitario Principe de Asturias

Collaborator

Quirón Madrid University Hospital

Collaborator

Universidad Autonoma de Madrid

Collaborator

Centro de Investigación Biomédica en Red de Salud Mental

Collaborator

Puerta de Hierro University Hospital

Collaborator