Prospective Assessment of Cost-effectiveness and Side-effects of Depressive Patients Treated With ECT or TCA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Effectiveness of treatment as measured by reduction on HDRS-17
研究概览
简要总结
Prospective observational cohort study to determine cost-effectiveness of ECT compared to medication in the treatment of major depressive disorder (MDD) in the Netherlands.
详细描述
Rationale:
Currently, detailed information on the cost-effectiveness of ECT based on real-world data is lacking, as well as the comparative cost-effectiveness with respect to medication. Reliable information on outcomes of ECT in comparison with antidepressant treatment and its cognitive side-effects is needed for patients and clinicians to make a balanced and shared decision regarding choosing or refraining from ECT.
Objective:
Primary Objective: determine (cost)-effectiveness of ECT compared to medication by determining the impact of treatment for MDD with ECT or TCA on remission rates using a one-year time horizon (trial-based economic evaluation)
Secondary Objective: determine side-effects of ECT compared to medication by determining the impact of treatment with ECT or medication on side-effects and quality of life during a one-year follow-up
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
- •adult patients (>18 years) with a major depressive disorder who will either start with ECT or medication
- •failed response to at least 1 adequate dose-duration trial with antidepressants
- •moderate or severe depression (HDRS-17 >16)
排除标准
- •lifetime diagnosis schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome
- •the presence of a concurrent significant medical condition impeding the ability to participate
研究组 & 干预措施
ECT group
110 participants with primary diagnosis of moderate to severe major depressive disorder receiving ECT as treatment
干预措施: Electroconvulsive therapy (ECT) (Procedure)
Medication group
110 participants with primary diagnosis of moderate to severe major depressive disorder receiving medication as treatment
结局指标
主要结局
Effectiveness of treatment as measured by reduction on HDRS-17
时间窗: change from baseline at 3 months, 6 months and 12 months
Depression severity measured by The Hamilton Depression Rating Scale 17 item version (HDRS-17)
次要结局
- Cognitive functioning as measured by Montreal Cognitive Assesment (MoCA)(change from baseline at 3 months, 6 months and 12 months)
- Cost-effectiveness as measured with The Trimbos Institute and iMTA Cost questionnaire for Psychiatry (TiC-P)(change from baseline at 3 months, 6 months and 12 months)
- COLUMBIA UNIVERSITY - AUTOBIOGRAPHICAL MEMORY INTERVIEW SHORT FORM (CU-AMI-SF)(change from baseline at 3 months, 6 months and 12 months)
- Subjective Assessment of Memory Impairment (SAMI)(change from baseline at 3 months, 6 months and 12 months)
- Quality of life as measured with the EuroQol-5D (EQ-5D-5L)(change from baseline at 3 months, 6 months and 12 months)
- 15 words test (15WT)(change from baseline at 3 months, 6 months and 12 months)
- Verbal fluency test (e.g., Lezak et al., 2012).(change from baseline at 3 months, 6 months and 12 months)