Long-term Study With Trazodone Once-a-Day

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04295941

Collaborator

(none)

233

Enrollment

Location

24.2

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the present observational study is to assess the clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who demonstrated an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, for up to 24 weeks.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: TraZODone Hydrochloride 300 MG

Detailed Description

This is an observational, prospective, single group, multicentre, international study.

The present study is planned to assess, in a real-world setting, the long-term clinical response, functional impairment and quality of life in outpatients with Major Depressive Disorder who, according to the physician's judgment, have responded to the acute monotherapy (6 to 8 weeks of treatment) with Trazodone once-a-day and are eligible to continue Trazodone once-a-day monotherapy according to clinical practice.

Study Design

Study Type:

Observational

Anticipated Enrollment :

233 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long-term Treatment With Trazodone Once-a-Day (TzOAD) in Patients With MDD: an Observational, Prospective Study

Actual Study Start Date :

Jun 23, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Trazodone once-a-day treated patients Major Depressive Disorder outpatients who, following an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, will be eligible to enter the continuation therapy and will be observed up to 24 weeks.	Drug: TraZODone Hydrochloride 300 MG Oral administration of Trazodone once-a-day.

Arm

Intervention/Treatment

Trazodone once-a-day treated patients

Major Depressive Disorder outpatients who, following an initial positive response to the acute treatment with Trazodone once-a-day monotherapy, will be eligible to enter the continuation therapy and will be observed up to 24 weeks.

Drug: TraZODone Hydrochloride 300 MG

Oral administration of Trazodone once-a-day.

Outcome Measures

Primary Outcome Measures

Clinical Global Impression-improvement scale responders percentage [24(+4) weeks]
The clinical response expressed as CGI-I responders' percentage at 24 (+ 4) weeks.

Secondary Outcome Measures

Clinical Global Impression-improvement scale responders percentage [12 (+ 3) weeks.]
The clinical response expressed as CGI-I responders' percentage at 12 (+ 3) weeks.
Clinical Global Impression-improvement scale responders percentage [18 (+ 3) weeks]
The clinical response expressed as CGI-I responders' percentage at 18 (+ 3) weeks.
Sheehan Disability Scale score [24-week period]
The functional impairment evaluated over the 24-week period
EQ-5D-5L Quality of life scale [24-week period]
The quality of life evaluated over the 24-week period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female patients of any ethnic origin ≥18 years old at Baseline. Outpatients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 or the International Classification of Diseases (ICD)-10 criteria for MDD as their primary diagnosis and presenting with an episode of MDD.

Patients judged as responders to the acute monotherapy with TzOAD after a minimum of 6 and a maximum of 8 weeks of treatment and who are eligible to continue the assigned monotherapy according to the physician's judgement.

Patients legally capable of giving their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.

Exclusion Criteria:

Patients that meet any of the contraindications to the administration of TzOAD according to the approved SmPC.

Patients with previous or current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, dysthymic or adjustment disorders, mental retardation, organic mental disorders or mental disorders due to a general medical condition.

Patients with previous or current history of a clinically significant neurological disorder, or any neurodegenerative diseases that might compromise the participation in the study.

Patients who are, according to the physician's judgement, at serious risk of suicide.

Patients with substance abuse or dependence (except nicotine dependence), as defined by DSM-5.

Patients participating in any pharmacological or non-pharmacological interventional study.