"KETTLE" Trial: Ketamine Effects on Learning In Eating Disorders
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Reversal Learning
研究概览
简要总结
This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-26 years old
- •Meets diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (atypical AN) per DSM-5 criteria on admission
- •Admitted to the medical hospital for malnutrition
- •No changes to psychiatric medications for month prior to trial enrollment
- •Agree to use a highly effective form of contraception for at least two weeks following ketamine administration
- •Have an outpatient primary care provider, medical provider, or behavioral health provider or psychiatrist who is actively managing or coordinating care
排除标准
- •Lifetime history of any psychotic disorder
- •Moderate or severe substance use disorder
- •Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial
- •Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment
- •Intellectual or developmental disability
- •High risk for self-harm/suicide
- •Active laxative misuse or abuse
- •Biochemical refeeding syndrome or electrolyte abnormality
- •Cardiac abnormalities identified on admission
- •Taking medications that would be unsafe to administer with ketamine
- •Other medical condition or diagnosis, physical exam finding, laboratory abnormality, or health risk that would increase the risk of adverse events, at the discretion of the investigators
研究组 & 干预措施
Ketamine Infusion
干预措施: Ketamine infusion (Drug)
结局指标
主要结局
Mean Change From Baseline in Reversal Learning
时间窗: Day 2, Day 4
Mean change in reversal learning as measured by the probabilistic reversal learning task.In the task, participants are presented with two stimuli, told to choose one of the two stimuli on each trial, and receive feedback regarding whether the stimulus is "Correct" or "Incorrect." Participants must modify their choice based on c hanging stimulus-outcome contingencies over time, engaging flexible learning.
次要结局
未报告次要终点
研究者
Amanda Downey, MD
Assistant Professor of Pediatrics and Psychiatry and Behavioral Sciences
University of California, San Francisco