Clinical trial NCT06989944: Physical Activity-based Intervention in Depressed Patients: Clinical, Neurophysiological, Epigenetic and Metabolic Correlates
Official title: Physical Activity-based Intervention in Depressed Patients: Clinical, Neurophysiological, Epigenetic and Metabolic Correlates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: Major depressive disorder
physical activity
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
name: Istituto Neurologico Mediterraneo Neuromed S. R. L
name: Azienda Sanitaria Locale di Pescara
First posted: 2025-05-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled design
Primary purpose: SUPPORTIVE_CARE

Brief 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 and neurophysiological profiles in patients affected by depression?
* What are the 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).

Throughout the 12-week PA program, participants will keep a diary of their physical activity (minutes per day) and sleep patterns (hours per night).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Primary diagnosis of depression (DSM-5 criteria)
* Symptoms of depression according to MADR, BDI, ZDR Scale
* Ability to provide written IC
* Self-reported moderate-intensity leisure PA\< 150 min/week

Exclusion Criteria:

* Severe psychopathology
* Medical contraindications to PA (PAR-Q)
* Orthopedic problems/diseases which limit physical fitness assessment
* Currently pregnant (or planning to become pregnant)

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline (day one), Month 3 (up to three months; end of treatment), Month 6 (up to 6 months; follow up).
measure: Beck Depression Inventory - II
timeFrame: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
measure: Zung Self-Rating Depression Scale
timeFrame: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
measure: Personal and Social Performance Scale
timeFrame: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
measure: World Health Organization Quality of Life - Bref
timeFrame: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
Secondary outcomes:
measure: EEG-derived neurophysiological metrics, including spectral, coherence, source localization, and graph-based connectivity measures
timeFrame: Baseline (Day 1); Month 3 (up to 3 months; end of treatment); Month 6 (up to 6 months, follow - up)
measure: Immunitary-related factors levels
timeFrame: Baseline (Day 1); Month 3 (up to 3 months; end of treatment)
measure: Heart Rate Variability
timeFrame: 24h/day for 7 days before baseline, months 3 (at the end of the trial) and month 6 (up to 6 months follow up)
measure: Differentially Expressed genes and biological pathways modulation
timeFrame: Baseline (Day 1); Month 3 (up to 3 months; end of treatment)
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni fi Dio Fatebenefratelli
city: Isernia
country: Italy
facility: Istituto Neurologico Mediterraneo Neuromed, NEUROMED
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Pescara
country: Italy
facility: Azienda Sanitaria Locale di Pescara
Study officials:
References: