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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Mar 1, 2026 to Aug 1, 2026
    • Site details revised at 4 of 4 sites
    v3
  3. Minor Primary completion date: Feb 1, 2026 to Mar 1, 2026
    • Study completion date: Feb 1, 2026 to Feb 1, 2027
    • Secondary endpoints: 4 to 5
    • Site details revised at 4 of 4 sites
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06989944
Lead Sponsor IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborators: IRCCS San Raffaele, Istituto Neurologico Mediterraneo Neuromed S. R. L, Azienda Sanitaria Locale di Pescara
Conditions
(from sponsor)
Major Depressive Disorder (MDD)
Related terms Major Depressive Disorder, Motor Activity
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov