Long-term Study With Trazodone Once-a-Day

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1510
    • Medical Center Hera EOOD - Clinic/Outpatient Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-improvement scale responders percentage	The clinical response expressed as CGI-I responders' percentage at 24 (+ 4) weeks.	24(+4) weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; Trazodone once-a-day; Long term therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Antidepressive Agents, Second-Generation; Trazodone
• Other Study ID Numbers: 039(C)WO19201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No