SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)
SUBDIMA Study: Subclinical Depression in Myocardial Infarction -Prevalence, Predictors and Prognostic Impact.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
100 participants
Oct 14, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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
Exclusion Criteria7
- Previous history of acute myocardial infarction
- Diagnosis of major depression according to DSM-5 TR criteria
- Severe cognitive impairment (MMSE \<26)
- Severe comorbidities with expected survival \<12 months
- Inability to participate in scheduled follow-up assessments
- Refusal or inability to provide informed consent
- Concurrent participation in other interventional clinical studies that could interfere with study outcomes
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Interventions
Structured evaluation including PHQ-9, BDI-II, HAM-A, cognitive tests (CVLT-2, Matrici Attentive, Rey-Osterrieth), and validated questionnaires (EQ-5D-5L, PSQI, IPAQ, Medi-Lite, MARS-5) administered at baseline and during follow-up (3, 6, 9, and 12 months).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07492537