Actively Recruiting
Real-world Clinical Response to Trazodone in Italy, Poland, and Romania
Led by Aziende Chimiche Riunite Angelini Francesco S.p.A · Updated on 2026-01-30
120
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
A
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead Sponsor
I
IQVIA Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Real-world Clinical Response to Trazodone in Italy, Poland, and Romania
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 60 at enrolment.
- Patients with a diagnosis of Mild Cognitive Impairment (MCI) 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 within one week.
- Patients legally capable of giving their written consent and willing to comply with study procedures as judged clinically.
You will not qualify if you...
- Patients with contraindications to trazodone according to local approved SmPC.
- Known allergy or hypersensitivity to trazodone or any component of the medication.
- Receiving other antidepressants, mood stabilizers, antipsychotics, or proven resistance to trazodone alone.
- Current diagnosis of bipolar disorder, schizophrenia, other psychotic disorders, severe personality disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition.
- History of neurological conditions that may affect study participation as judged by the investigator.
- Participation in any interventional study within 30 days before enrolment.
- Pregnant or breastfeeding at the time of enrolment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. Poland
Lodz, Poland, Poland, 93-005
Actively Recruiting
Research Team
A
Alessandro Ruggieri
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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