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Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. Poland
RECRUITING
Lodz
Contact Information
Primary
Alessandro Ruggieri
alessandro.ruggieri@angelinipharma.com
+393475665012
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-07
Participants
Target number of participants: 120
Related Therapeutic Areas
Sponsors
Collaborators: IQVIA Pty Ltd
Leads: Aziende Chimiche Riunite Angelini Francesco S.p.A

This content was sourced from clinicaltrials.gov