Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Depressive symptoms severity (MADRS)
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Depressive symptoms severity (MADRS)
Time Frame: At 24 weeks from treatment
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.
Secondary Outcomes
- 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)
- Absolute and relative frequency of patients(Over 24 weeks)
- Serious adverse events of prolonged release trazodone(Over 24 weeks)
- Drug related adverse events of prolonged release trazodone(Over 24 weeks)