Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- EuroQOL 5 Dimensions EQ-5D-5L)
研究概览
简要总结
Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in outpatient psychiatry practices in the United States (US), as well as to describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more.
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
- •Patient has a cumulative lifetime exposure to antipsychotic medication of three months or more
- •Patient has a clinician confirmed diagnosis of one or more psychiatric disorder(s), as defined in the DSM-5
- •Patient has a usual care clinic visit scheduled during the study recruitment window (i.e. a pre-defined 2-week period)
- •Patient is able to read and understand English
- •Patient is willing and able to comply with the study requirements
排除标准
- •Patient is unable to provide informed consent.
结局指标
主要结局
EuroQOL 5 Dimensions EQ-5D-5L)
时间窗: 12 months
General, single index measure for describing and valuing health-related quality of life.
Customized clinician-reported outcomes
时间窗: 12 months
Clinician evaluation of patient burden due to tardive dyskinesia symptoms
Customized caregiver-reported outcomes:
时间窗: 12 months
Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver
Sheehan Disability Scale (SDS)
时间窗: 12 months
Assessment of functional impairment and disability
次要结局
未报告次要终点