NCT03207282已完成不适用
Treatment Resistant Depression in America Latina
Janssen-Cilag, S.A.33 个研究点 分布在 4 个国家目标入组 1,539 人开始时间: 2017年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,539
- 试验地点
- 33
- 主要终点
- Healthcare Resource Utilization in TRD Participants
研究概览
简要总结
The purpose of this study is to estimate the prevalence of Treatment Resistant Depression (TRD) among Major Depressive Disorder (MDD) participants being treated in a psychiatry reference site (example, clinic, ambulatory, hospital, day-hospital) in 4 Latin American countries: Argentina, Brazil, Colombia and Mexico; and to evaluate all and depression-related healthcare resource utilization in TRD participants.
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
- •Major depressive disorder (MDD) diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), that was confirmed by MINI International Neuropsychiatric Interview, 5.0 version (MINI)
- •Treated or untreated participants with a new or continued episode of depression at the time of the enrolment
- •Participants must be capable of completing the corresponding assessments in the study
- •Participants must be capable of signing the informed consent form
- •Diagnosis of Treatment Resistant Depression (TRD), to be described by the investigator, based on the criteria:
- •Adequate follow-up and treatment with at least 2 antidepressants
- •Without complete response to treatment (based on Montgomery-Asberg Depression Rating Scale [MADRS])
排除标准
- •Participants diagnosed of psychosis, schizophrenia, bipolar disorder, schizoaffective disorder, or dementia
- •Participants with substance dependence considered serious by the investigator
- •Participant currently participating in another clinical study
结局指标
主要结局
Healthcare Resource Utilization in TRD Participants
时间窗: Up to Month 12
Healthcare resources utilized in TRD participants will be estimated.
Percentage of Participants With Treatment Resistant Depression (TRD)
时间窗: Baseline (Day 1)
Prevalence of TRD will be assessed as percentage of participants with TRD among Major Depressive Disorder (MDD) participants.
次要结局
- Demographic Characteristics of TRD Participants(Baseline (Day 1))
- Treatment Patterns Over Time for TRD Participants(Baseline (Day 1) up to Month 12)
- Indirect Cost Associated With Work Productivity Loss(Baseline (Day 1) up to Month 12)
- Level of Disability as Measured by Sheehan Disability Scale (SDS)(Baseline (Day 1), Month 6, and 12)
- Indirect Cost Associated With Daily Functioning Loss(Baseline (Day 1) up to Month 12)
- Treatment Duration for MDD(Baseline (Day 1) up to Month 12)
- Treatment Pattern for TRD Participants by Line(Baseline (Day 1) up to Month 12)
- Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Score(Baseline (Day 1), Month 3, 6, 9 and 12)
- Indirect Cost Associated With Caregiver Burden(Baseline (Day 1) and Month 12)
- Number of Participants With Comorbid Conditions(Baseline (Day 1))
- Sequence of Drugs(Baseline (Day 1) up to Month 12)
- Healthcare Costs in TRD Participants(Up to Month 12)
- Indirect Cost Associated With Quality of Life(Baseline (Day 1) and Month 12)
- Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score(Baseline (Day 1), Month 3, 6, 9, and 12)
研究者
研究点 (33)
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