NCT07377682 Real-world Clinical Response to Trazodone in Italy, Poland, and Romania
| NCT ID | NCT07377682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aziende Chimiche Riunite Angelini Francesco S.p.A |
| Condition | Depression - Major Depressive Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-12-15 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Raffaele Antonelli Incalzi
PRINCIPAL INVESTIGATOR
CAMPUS BioMedico
Frequently Asked Questions
Who can join the NCT07377682 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07377682 currently recruiting?
Yes, NCT07377682 is actively recruiting participants. Contact the research team at alessandro.ruggieri@angelinipharma.com for enrollment information.
Where is the NCT07377682 trial being conducted?
This trial is being conducted at Lodz, Poland.
Who is sponsoring the NCT07377682 clinical trial?
NCT07377682 is sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. The principal investigator is Raffaele Antonelli Incalzi at CAMPUS BioMedico. The trial plans to enroll 120 participants.
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