Long-term Study With Trazodone Once-a-Day

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    233
  • sponsor
    Aziende Chimiche Riunite Angelini Francesco S.p.A
Updated on 30 October 2021
psychiatric disorder
major depressive disorder

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.

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.

Details
Condition Endogenous depression, Major depression, major depressive disorders, major depressive disorder
Treatment TraZODone Hydrochloride 300 MG
Clinical Study IdentifierNCT04295941
SponsorAziende Chimiche Riunite Angelini Francesco S.p.A
Last Modified on30 October 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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