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Physical Activity-based Intervention in Depressed Patients: Clinical, Neurophysiological, Epigenetic and Metabolic Correlates

NCT06989944 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-25

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate the effect of a structured physical activity (PA) program on depressive symptomatology in adults with a diagnosis of major depression disorder (MDD). The study will evaluate changes in depressive symptoms and assess neurophysiological and biological modulations, including epigenetic, transcriptomic, and metabolic changes resulting from the PA intervention. The main questions it aims to answer are:

* Does physical activity have an impact on depressive symptoms in patients affected by depression?
* What are the neurophysiological, epigenetic, and metabolic mechanisms through which PA can modulate the intensity of depressive symptoms?

Participants will be randomized into two arms: the intervention group (n total=55), in treatment with antidepressants, participating in a 12-weeks PA program; the control group (n total=55), patients in treatment with antidepressants, without receiving the PA program.

All participants will be assessed at three-time points: T0 (baseline, before initiating the trial), T3 (after three months; at the end of the 12-week PA program), and T6 (6th-month follow up; three months after the PA completion).

At each assessment, all participants will:

* Complete clinical evaluation questionnaires
* Provide blood samples
* Undergo electroencephalogram (EEG) measurements.
* Wear an actigraph 24 hours a day for 7 days before the initiation of the trial, at T3, and at T6.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

BEHAVIORAL

Physical Activity (PA) program

Participants assigned to the PA-arm will participate in at least three weekly 30-minute sessions of PA for a total of 12 weeks. The PA program will be tailored to individuals' characteristics, skills and preferences, based on information collected in connection with the baseline assessment and physical examination. A PA program could preview some forms of aerobic/relaxation/anaerobic exercises

Sponsors & Collaborators

  • IRCCS San Raffaele

    collaborator OTHER

  • Istituto Neurologico Mediterraneo Neuromed S. R. L

    collaborator OTHER

  • Azienda Sanitaria Locale di Pescara

    collaborator OTHER

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-08-01
Completion
2027-02-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989944 on ClinicalTrials.gov