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Completed

NCT Number: NCT04295941

Long-term Study With Trazodone Once-a-Day

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center Hera EOOD - Clinic/Outpatient Facility

Sofia, 1510, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TraZODone Hydrochloride 300 MG

Drug

Oral administration of Trazodone once-a-day.

Primary outcomes

  1. Clinical Global Impression-improvement scale responders percentage

    Time frame: 24(+4) weeks

    The clinical response expressed as CGI-I responders' percentage at 24 (+ 4) weeks.

Secondary outcomes

  1. Clinical Global Impression-improvement scale responders percentage

    Time frame: 12 (+ 3) weeks.

    The clinical response expressed as CGI-I responders' percentage at 12 (+ 3) weeks.

  2. Clinical Global Impression-improvement scale responders percentage

    Time frame: 18 (+ 3) weeks

    The clinical response expressed as CGI-I responders' percentage at 18 (+ 3) weeks.

  3. Sheehan Disability Scale score

    Time frame: 24-week period

    The functional impairment evaluated over the 24-week period

  4. EQ-5D-5L Quality of life scale

    Time frame: 24-week period

    The quality of life evaluated over the 24-week period

Sponsors and collaborators

Lead sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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