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

Launched by IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how a structured physical activity program can help adults with major depressive disorder (MDD). The study will explore whether participating in regular exercise can improve feelings of depression and also examine changes in the brain and body that might explain these improvements. Participants will be divided into two groups: one group will join a 12-week exercise program while continuing their usual antidepressant treatment, and the other group will continue their antidepressant treatment without any additional exercise program.

To be eligible for this trial, participants should be over 18 years old and have a primary diagnosis of depression. They should also report engaging in moderate physical activity for less than 150 minutes per week. During the study, all participants will have their depression symptoms evaluated through questionnaires, provide blood samples, and undergo brain activity tests. Additionally, they will keep a diary of their physical activity and sleep patterns. The trial will take place over a period of six months, with assessments at the beginning, after three months, and again three months later. This study aims to provide valuable insights into how exercise might help improve mental health in individuals facing depression.

Gender

ALL

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)