Long-term Study With Trazodone Once-a-Day

NCT ID: NCT04295941

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2021-11-16

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.

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.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

TraZODone Hydrochloride 300 MG

Intervention Type: DRUG

Oral administration of Trazodone once-a-day.

Interventions

TraZODone Hydrochloride 300 MG

Oral administration of Trazodone once-a-day.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Center Hera EOOD - Clinic/Outpatient Facility

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

039(C)WO19201

Identifier Type: -

Identifier Source: org_study_id