Optimal Electrical Stimulus During Electroconvulsive Therapy for Depression: a National Register-based Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Remission
研究概览
简要总结
Synopsis
Aim: The purpose of the study is to determine the stimulus of electrical current during electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare the 0.5 ms and 1.0 ms pulse width stimuli.
Design: National, register-based randomized trial, unmasked with two treatment arms.
Primary objective: To test the hypothesis that a 1.0 ms pulse width stimulus produces a higher remission rate (< 11 on the MADRS-S) than a 0.5ms pulse width stimulus.
Secondary objectives include testing for differences in:
self-rated global health measured with the EQ5D-VAS subjective memory worsening (increase of 2 on the memory item of the CPRS) antidepressive response (decrease of 50% on the MADRS-S) number of ECTs in the treatment series readmission and suicide rate within 6 months Study population: patients with unipolar or bipolar depression. Sample size: 800 patients, 400 patients in each arm.
Inclusion criteria:
At least 18 years of age at the time of inclusion Diagnostic criteria fulfilled for unipolar, or bipolar depressive episode according to ICD-10.
An indication for and accepting ECT A Swedish personal identity number. Capable of giving informed consent.
Exclusion criteria:
If the investigator judges a certain pulse width to be inappropriate for the patient.
Inclusion time 2019-05-01-2022-11-15.
Abbreviations
- CGI: Clinical Global Impression Scale
- CPRS: The Comprehensive Psychopathological Rating Scale
- ECT: Electroconvulsive therapy
- EQ5D: EuroQual-group 5 Dimensions Scale
- ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision,
- MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version.
- Q-ECT: Swedish national quality register for ECT
- VAS: Visual analogue scale
详细描述
Purpose and aims The purpose of the study is to determine the electrical current stimulus for electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare 0.5 ms and 1.0 ms pulse width stimuli.
Primary objective: To test the hypothesis that a 1.0 ms pulse width produces a higher remission rate (< 11 on the Montgomery-Åsberg Depression Rating Scale, self assessed version (MADRS-S)) than a 0.5 ms pulse width within 1 week after the treatment series.
The secondary objectives are to test for differences in:
- self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual analogue scale (EQ5D-VAS)
- subjective memory worsening (increase of 2 on the memory item of the Comprehensive Psychopathological Rating Scale (CPRS))
- antidepressive response (decrease of 50% on the MADRS-S)
- number of ECTs in the treatment series
- readmission and suicide rate within 6 months
- self-rated global health measured with the EQ5D-VAS at 6 month follow-up
- subjective memory worsening (increase of 2 on the memory item of the CPRS) at 6 month follow-up
- remission rate (< 11 on MADRS-S) at 6 month follow-up
Hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years old at the time of inclusion
- •Fulfilled diagnostic criteria for unipolar, or bipolar depressive episode according to ICD-
- •Has indication for and accepts ECT
- •Has a Swedish personal identity number
- •Capable of giving informed consent
排除标准
- •If the investigator judges a certain pulse width to be inappropriate for the patient.
研究组 & 干预措施
0.5 ms pulse width stimulus
Electroconvulsive therapy initiated with 0.5 ms pulse width stimulus
干预措施: Electroconvulsive therapy (Device)
1.0 ms pulse width stimulus
Electroconvulsive therapy initiated with 1.0 ms pulse width stimulus
干预措施: Electroconvulsive therapy (Device)
结局指标
主要结局
Remission
时间窗: within 1 week after treatment termination
To test the hypothesis that a 1.0 ms pulse width produces a higher remission rate (\< 11 on the Montgomery-Åsberg Depression Rating Scale, self assessed version (MADRS-S)) than a 0.5 ms pulse width within 1 week after the treatment series. The scales has 9 items each ranging from 0-6. The score of each item is added together. The maximum total score of the scale is 54, the minimum is 0. Higher scores indicate more severe depressive symptoms.
次要结局
- Self rated health status(at 6 month follow-up)
- Number of sessions(During index-treatment)
- readmission and suicide(within 6 months)
- Subjective memory(at 6 month follow-up)
- Antidepressive response(within 1 week after treatment termination)
- remission rate(at 6 month follow-up)
- Self rated health status(within 1 week after treatment termination)
- Subjective memory(within 1 week after treatment termination)