SUBDIMA: Subclinical Depression in Acute Myocardial Infarction (SUBDIMA25)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Psychological, Cognitive, and Patient-Reported Outcome Assessments

Treatment groups

100 Participants
are divided into 2 treatment groups