Trazodone for older adults with major depression and mild cognitive impairment in Italy, Poland, and Romania
Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)
This will see if prolonged-release trazodone helps people aged 55+ with major depressive disorder and mild cognitive impairment when prescribed in routine care in Italy, Poland, and Romania.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Aziende Chimiche Riunite Angelini Francesco S.p.A Industry-sponsored |
| Locations | 1 site (Lodz, Poland) |
| Trial ID | NCT07377682 on ClinicalTrials.gov |
What this trial studies
TRACOMDD is an observational effort collecting real-world data on prolonged-release trazodone started in routine clinical care by adults aged 55 and older with DSM-5 major depressive disorder and mild cognitive impairment. Eligible patients must have a current depressive episode of at least moderate severity (MADRS ≥20) and begin trazodone per the local SmPC at or within one week of enrollment. Investigators will record clinical response, safety, and tolerability using routine clinical assessments and rating scales (for example, MADRS) during follow-up visits. Data will be gathered from participating centers in Italy, Poland, and Romania to describe how trazodone is used and how patients do in everyday practice.
Who should consider this trial
Good fit: Adults aged 55 or older with DSM-5 major depressive disorder currently experiencing a moderate-to-severe episode (MADRS ≥20) and a DSM-5 diagnosis of mild cognitive impairment who are starting prolonged-release trazodone per the SmPC.
Not a fit: People with contraindications to trazodone or known hypersensitivity, those younger than 55, or those not initiating trazodone are unlikely to gain direct benefit from participating.
Why it matters
Potential benefit: If successful, the results could help clinicians know whether prolonged-release trazodone reduces depressive symptoms and is well tolerated in older adults with mild cognitive impairment.
How similar studies have performed: Trazodone has shown antidepressant effects in prior clinical work, but real-world data focused specifically on older adults with coexisting mild cognitive impairment are limited, so this approach is partially supported but relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 55 or older. * Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis. * Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment. * Patients with a diagnosis of MCI (also referred to as "mild neurocognitive disorder") according to the DSM-5 criteria. * Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week). * Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures as per clinical judgement. Exclusion Criteria: * Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC. * Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication. * Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and/or proved resistance to trazodone monotherapy. * Patients with current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition. * Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study. * Patients participating in any interventional study in the 30 days prior to the enrolment visit. * Patients with ongoing pregnancy or breast-feeding at enrolment visit.
Where this trial is running
Lodz, Poland
- Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. Poland — Lodz, Poland, Poland (Recruiting)
Study contacts
- Principal investigator: Raffaele Antonelli Incalzi — CAMPUS BioMedico
- Study coordinator: Alessandro Ruggieri
- Email: alessandro.ruggieri@angelinipharma.com
- Phone: +393475665012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.