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SUBDIMA Study: Subclinical Depression in Myocardial Infarction -Prevalence, Predictors and Prognostic Impact.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is an exploratory, prospective, non-profit study (SUBDIMA) designed to investigate the prevalence and potential prognostic significance of subclinical depression in patients admitted with a first acute myocardial infarction (AMI). Subclinical depression refers to the presence of mild depressive symptoms (PHQ-9 score 5-9) that do not meet DSM-5 TR criteria for major depressive disorder but may still be clinically relevant. The primary aim is to estimate the prevalence of subclinical depression in this setting. Secondary, exploratory objectives include evaluating associations with inflammatory and metabolic biomarkers, autonomic dysfunction, cardiac function, cognitive performance, quality of life, treatment adherence, and the risk of recurrent cardiovascular events over 12 months. The study is expected to generate new descriptive data that may inform future confirmatory trials and support early, personalized approaches to integrated cardiac and mental health care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Hospital admission for first acute myocardial infarction (STEMI or NSTEMI) within 7 days from the index event

• PHQ-9 administered at screening

• Mini Mental State Examination (MMSE) score ≥26

• Written informed consent obtained

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia
RECRUITING
Roma
Contact Information
Primary
Fabio Infusino, MD, PhD
fabio.infusino@policlinicogemelli.it
+390630154187
Backup
Federica Mammarella, MD, PhD
federica.mammarella@policlinicogemelli.it
+390630154187
Time Frame
Start Date: 2025-10-14
Estimated Completion Date: 2027-10
Participants
Target number of participants: 100
Treatments
Other: AMI + Subclinical Depression group
Patients with 1st AMI and PHQ-9 score between 5 and 9 and no DSM-5 TR criteria for major depression. These participants undergo all study assessments at baseline and follow-up (3, 6, 9, and 12 months).
Other: AMI NO Subclinical Depression Group
Patients with 1st AMI and PHQ-9 score \<5 and no DSM-5 TR criteria for major depression. These participants undergo the same study assessments as the Subclinical Depression Group (baseline and follow-up at 3, 6, 9, and 12 months).
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov