An interventional study of Psychological, Cognitive, and Patient-Reported Outcome Assessments in Acute Myocardial Infarction and Subclinical Depression, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Other
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Among 101 studies in Depression with a site in Italy — 31 open to participants now, 32 under way, 2 of them phase 3. Depression · Italy.
Among the 101 studies in Depression with a site in Italy, this one is the 38th largest by planned enrollment of the 74 interventional ones that give a count, is one of 12 that started in 2025, is one of 47 with no phase, reaches primary completion later than 19 of the 31 other live ones, and was the 96th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →31 of the 101 studies in Depression with a site in Italy are open now. Recruiting first, the newest first:
IRCCS Centro San Giovanni di Dio Fatebenefratelli · Sites in Italy
Ages 65–85
IRCCS Centro Neurolesi Bonino Pulejo · Sites in Italy
Ages 18–60
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+
IRCCS Centro San Giovanni di Dio Fatebenefratelli · Sites in Italy
Ages 50–80
IRCCS Policlinico S. Donato · Sites in Italy
Ages 18+ · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
101 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 12 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 102 across the 74 interventional studies, 200 across the 27 observational. Of the 50 that completed or were terminated, 10 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 101 have an industry lead sponsor. The 10 most frequent:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS has 5 studies filed under Depression — fewer than ten, so there is no comparison to draw.
3 of the studies in Depression with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589544University Hospital of FerraraNon-pharmacological Care for Depression in Cancer Patients Using VR and TMS | 2026-12-31 |
| NCT06724029Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaNeurosurgical Outcome Network | 2027-06 |
| NCT06395558Azienda Usl di BolognaintErnet-based iNterventions FOR Cardiac arrEst suRvivors | 2027-08-05 |
Add all 3 to your calendar (.ics) → With an account.
Among the 101 studies in Depression with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Depression is a recognized risk factor for adverse outcomes in patients with acute coronary syndromes. While most studies have focused on major depressive disorder, subclinical depression (defined as PHQ-9 scores between 5 and 9 in the absence of DSM-5 TR criteria for major depression) remains poorly characterized. Its prevalence in patients with a first acute myocardial infarction (AMI) is largely unknown, as are its potential associations with clinical, biological, and psychosocial outcomes.
The SUBDIMA study is a prospective, exploratory, single-center, non-profit clinical investigation conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS. Consecutively admitted patients with a first AMI will undergo systematic screening with the PHQ-9 and a structured clinical assessment to exclude major depression. Based on these evaluations, patients will be classified into two groups: with or without subclinical depression. All participants will be followed for 12 months, with visits at baseline, 3 months, and 12 months, and intermediate phone contacts at 6 and 9 months.
The primary aim of the study is descriptive: to estimate the prevalence of subclinical depression in this population. Secondary, exploratory aims are to examine potential associations between subclinical depression and:
Given its exploratory design, the study is not powered to test confirmatory hypotheses. Instead, it is expected to provide novel descriptive data that will inform the design of future confirmatory trials and contribute to the integration of psychosocial screening in cardiology care pathways.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Psychological, Cognitive, and Patient-Reported Outcome Assessments
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).
Other: Psychological, Cognitive, and Patient-Reported Outcome Assessments
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).
Prevalence of Subclinical Depression in Patients with First Acute Myocardial Infarction
Proportion of patients with PHQ-9 score between 5 and 9 who do not meet DSM-5 TR criteria for major depression among those admitted with first acute myocardial infarction.
Time frame: Baseline (hospital admission)
C-reactive protein (CRP) levels
Differences in C-reactive protein (CRP) levels between patients with and without subclinical depression.
Time frame: Baseline, 3 months, and 12 months
Lipid profile
Differences in lipid profile parameters, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, between patients with and without subclinical depression. Each parameter will be analyzed separately.
Time frame: Baseline, 3 months, and 12 months
NT-proBNP levels
Differences in NT-proBNP levels between patients with and without subclinical depression.
Time frame: Baseline, 3 months, and 12 months
Cardiac function (LVEF and GLS)
Cardiac function assessed by left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS). Each parameter will be analyzed separately.
Time frame: Baseline, 3 months, and 12 months
Recurrent Cardiovascular Events
Incidence of recurrent ischemic events (AMI, stroke, peripheral ischemia), hospitalization for cardiovascular causes, and cardiovascular mortality.
Time frame: Up to 12 months
Quality of Life assessed with EQ-5D-5L and VAS
Quality of life assessed using the EuroQol-5D-5L (EQ-5D-5L), including utility index and visual analogue scale (VAS).
Time frame: Baseline, 3 months, and 12 months
Treatment Adherence
Differences in treatment adherence evaluated using the Medication Adherence Report Scale (MARS-5) total score.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Complete blood count (CBC) parameters
Differences in complete blood count parameters, including hemoglobin, white blood cell count, and platelet count, between patients with and without subclinical depression. Each parameter will be analyzed separately.
Time frame: Baseline, 3 months, and 12 months
Sleep Quality assessed with PSQI
Exploratory, descriptive analysis of sleep quality using the Pittsburgh Sleep Quality Index (PSQI).
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Physical Activity assessed with IPAQ
Physical activity assessed with International Physical Activity Questionnaire (IPAQ) score.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Dietary Pattern (Medi-Lite Score)
Dietary habits assessed with the Medi-Lite Score.
Time frame: Baseline, 3 months, and 12 months
Cognitive function (composite neuropsychological assessment)
Cognitive performance assessed using California Verbal Learning Test-II (CVLT-II), Attentive Matrices, and Rey-Osterrieth Complex Figure test.
Time frame: Baseline, 3 months, and 12 months
Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 12 months after the start.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →