Real-world Clinical Response to Trazodone in Italy, Poland, and Romania
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorAziende Chimiche Riunite Angelini Francesco S.p.A
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead sponsor
IQVIA Pty Ltd
Collaborator
Source ClinicalTrials.gov