Long-term Study With Trazodone Once-a-Day

NCT04295941 | Completed

• 1 other identifier: 039(C)WO19201
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Trazodone once-a-day; Major Depressive Disorder; Long term therapy

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-improvement scale responders percentage

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

  24(+4) weeks

Secondary Outcomes (4)

• Clinical Global Impression-improvement scale responders percentage

  12 (+ 3) weeks.

• Clinical Global Impression-improvement scale responders percentage

  18 (+ 3) weeks

• Sheehan Disability Scale score

  24-week period

• EQ-5D-5L Quality of life scale

  24-week period

Study Arms (1)

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

Interventions

TraZODone Hydrochloride 300 MG DRUG

Oral administration of Trazodone once-a-day.

Trazodone once-a-day treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Medical Center Hera EOOD - Clinic/Outpatient Facility

Sofia, 1510, Bulgaria

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: June 23, 2020
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

BU (1)