Trazodone for older adults with major depression and mild cognitive impairment in Italy, Poland, and Romania

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.