Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Group difference in change in question 6 score on Treatment Credibility and Expectancy Scale (CEQ-6)
研究概览
简要总结
The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.
详细描述
Primary Objective:
To determine whether a positive presentation before first treatment improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.
Secondary Objectives:
To determine whether a post-treatment follow up session to provide encouragement and reassurance improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.
To determine whether a positive presentation results in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score within 24 hours after the first treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only outcome assessors collecting MADRS are masked.
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
- •Participants must be either male or female and at least 18 years old
- •Deemed clinically appropriate to receive esketamine by a Yale Interventional Psychiatry physician.
- •Written consent for the study procedures
- •Ability and willingness, in the investigator's judgement, to comply with the study schedule, treatment plan, and other trial requirements for the duration of the study.
排除标准
- •Hearing or visual impairment to the degree that would interfere with ability to view the presentation
- •Difficulty in understanding spoken or written English
- •Unable to provide informed consent
- •Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the presentation (per investigator judgment)
- •Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
- •Previous Esketamine or ketamine treatment
- •Unable to give informed consent
- •Was previously enrolled/randomized into the trial
结局指标
主要结局
Group difference in change in question 6 score on Treatment Credibility and Expectancy Scale (CEQ-6)
时间窗: baseline and after presentation (before treatment 1), up to 30 days
Participants' expectations will be assessed by the change in the group score of item 6 of the CEQ-6 at baseline and after the presentation (before treatment 1). Item 6 is scored from 0% (not at all) to 100% (very much). Higher scores indicates expectations have been met.
Group Difference in Change in Question 6 Score on Treatment Credibility and Expectancy Scale (CEQ-6)
时间窗: baseline and after presentation (before treatment 1), up to 30 days
Participants' expectations will be assessed by the change in the group score of item 6 of the CEQ-6 at baseline and after the presentation (before treatment 1). Item 6 is scored from 0% (not at all) to 100% (very much). Higher scores indicates expectations have been met.
次要结局
- Group difference in change in Montgomery-Åsberg Depression Rating Scale (MADRS) score(baseline and within 24 hours post treatment 1)
- Group Difference in Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score(baseline and within 24 hours post treatment 1)