Real-world Clinical Response to Trazodone in Italy, Poland, and Romania

NCT07377682 | Recruiting

• 1 other identifier: 039(Z)MD24063
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression - Major Depressive Disorder; Cognition Disorders in Old Age

Keywords

Depression; Major Depressive Disorder; Cognition

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms severity (MADRS)

  To describe the response in terms of depressive symptoms severity (as measured by Montgomery-Åsberg Depression Rating Scale \[MADRS\]) start among patients with moderate-severe MDD and with MCI treated with prolonged release trazodone. The Montgomery-Åsberg Depression Rating Scale (MADRS) is a widely used clinician-rated scale designed to measure the overall severity of core symptoms of depression in patients with MDD. It consists of 10 items: nine of the items are based upon patient report and one is on the rater's observation during the rating interview. MADRS items are rated on a 7-point scale, where 0 refers to the lack of the symptom and 6 refers to the most severe level of the symptom. The total score is the sum of the items and ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms. The MADRS is completed by the Investigator at each scheduled visit and the results will be entered into the eCRF.

  At 24 weeks from treatment

Secondary Outcomes (8)

• Depressive symptoms severity (MADRS)

  At 12 weeks from treatment

• Clinical response (CGI)

  At 24 weeks from treatment

• Cognitive functioning (MoCA)

  At 24 weeks from treatment

• Sleep quality (SQS)

  At 24 weeks from treatment

• To describe the response in terms of quality of life (EQ-5D-5L)

  At 24 weeks from treatment

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Major Depressive Disorder and mild cognition impairment treated with trazodone

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IQVIA Solutions: collaborator
• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead

Study Sites (1)

Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. Poland

Lodz, Poland, 93-005, Poland

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Raffaele Antonelli Incalzi

  CAMPUS BioMedico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Ruggieri

CONTACT

+393475665012; alessandro.ruggieri@angelinipharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 30, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

PL (1)