NCT06989944

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2025-05-25
• Last updated: 2026-03-25

Locations

4 sites across 1 country: Italy