Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Depression severity
研究概览
简要总结
The goal of this clinical trial is to understand how patient education surrounding a one-time, consciousness-altering medical intervention impacts the antidepressant response to the intervention in adults with major depressive disorder. In this study, the consciousness-altering medical intervention is a single infusion of propofol, an intravenous anesthetic which might have antidepressant properties.
The main question this study aims to answer is: Does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol?
Researchers will compare response-focused vs. diagnosis-focused education.
Qualifying participants will:
- Undergo a single intravenous infusion of propofol which will induce a temporary state of sedation
- Wear an EEG cap that records brain activity during sedation
- Be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation
- Be asked to fill out surveys about their mood and other measures of well-being before and after treatment
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
- Double (Participant, Outcomes Assessor)
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
- •Diagnosis of major depressive disorder of at least moderate severity
- •Able to read, understand, and provide written informed consent
排除标准
- •Pregnant or breastfeeding
- •Certain substance use disorders
- •Daily use of opioids and/or benzodiazepines
- •History of psychosis, schizophrenia, or schizoaffective disorder
- •Body mass index greater than 35 kg/m2
- •Obstructive sleep apnea that is moderate and untreated, or severe
- •Any gastrointestinal condition placing the patient at significant risk of aspiration
研究组 & 干预措施
Response-focused education
Patient education that is focused on treatment response
干预措施: Response-focused education (Behavioral)
Diagnosis-focused education
Patient education that is focused on the diagnosis of major depressive disorder
干预措施: Diagnosis-focused education (Behavioral)
结局指标
主要结局
Depression severity
时间窗: From enrollment to 28 days after treatment
The 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR-16) assesses the severity of depressive symptoms experienced by an individual. Items are self-rated on a 4-point scale tailored to each depression symptom. Higher total scores indicate greater depression severity.
Change in clinician-rated depression severity
时间窗: From Day 0 pre-intervention baseline to 1, 2, and 3 days post-intervention
The Montgomery-Asberg Depression Rating Scale (MADRS) assesses the severity of depressive symptoms experienced by an individual. Items are clinician-rated on a 7-point scale tailored to each depression-related symptom (e.g. sleep, appetite, energy level). Higher total scores indicate greater depression symptom severity.
次要结局
- Antidepressant response rate(From Day 0 pre-intervention baseline to 1, 2, 3, 7, and 14 days post-intervention)
研究者
Theresa Lii
Principal Investigator
Stanford University