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NCT07377682Recruiting

Real-world Clinical Response to Trazodone 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)

Source: ClinicalTrials.gov · Last updated 30 Jan 2026

Brief summary (registry, in English)

TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
17 Dec 2025
Start date
15 Dec 2025
Primary completion date
31 Jul 2026
Lead sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Diseases
Depression
NCT number
NCT07377682

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 15 Dec 2025 to the primary completion date, 31 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and/or proved resistance to trazodone monotherapy.
  • 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.

Other illness

  • Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication.
  • 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.

Other

  • Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC.
  • Patients with ongoing pregnancy or breast-feeding at enrolment visit.

Who the study is looking for

  • 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.

Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. Poland
Coordinator of this site? Confirm its status
LodzPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.