Long-term Treatment With Trazodone Once-a-Day (TzOAD) in Patients With MDD: an Observational, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical Global Impression-improvement scale responders percentage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •Patients participating in any pharmacological or non-pharmacological interventional study.
研究组 & 干预措施
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.
干预措施: TraZODone Hydrochloride 300 MG (Drug)
结局指标
主要结局
Clinical Global Impression-improvement scale responders percentage
时间窗: 24(+4) weeks
The clinical response expressed as CGI-I responders' percentage at 24 (+ 4) weeks.
次要结局
- Sheehan Disability Scale score(24-week period)
- Clinical Global Impression-improvement scale responders percentage(18 (+ 3) weeks)
- EQ-5D-5L Quality of life scale(24-week period)