Impact of physical activity on depression in adults
Physical Activity-based Intervention in Depressed Patients: Clinical, Neurophysiological, Epigenetic and Metabolic Correlates
This study is testing if a 12-week exercise program can help adults with major depression feel better when combined with their usual antidepressant treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 4 sites (Brescia and 3 other locations) |
| Trial ID | NCT06989944 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a structured physical activity program on depressive symptoms in adults diagnosed with major depressive disorder (MDD). Participants will be randomly assigned to either an intervention group, which will engage in a 12-week physical activity program while receiving antidepressants, or a control group that will continue with antidepressants without the physical activity intervention. The study aims to evaluate changes in depressive symptoms and explore neurophysiological, epigenetic, and metabolic changes associated with the physical activity intervention. The research seeks to determine the impact of physical activity on both mental health and biological markers related to depression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a primary diagnosis of major depressive disorder and self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.
Not a fit: Patients with severe psychopathology, medical contraindications to physical activity, or orthopedic problems that limit physical fitness assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-pharmacological approach to alleviate depressive symptoms in patients with MDD.
How similar studies have performed: Other studies have shown promising results in using physical activity as an intervention for depression, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Brescia and 3 other locations
- IRCCS Centro San Giovanni fi Dio Fatebenefratelli — Brescia, Italy (Recruiting)
- Istituto Neurologico Mediterraneo Neuromed, NEUROMED — Isernia, Italy (Not_yet_recruiting)
- IRCCS Ospedale San Raffaele — Milano, Italy (Recruiting)
- Azienda Sanitaria Locale di Pescara — Pescara, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Davide V Moretti, PhD
- Email: dmoretti@fatebenefratelli.eu
- Phone: 0039 030 35501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.