Effects of Psilocybin in Anorexia Nervosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS)
研究概览
简要总结
This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely produced in people with AN when psilocybin is administered in a supportive setting with close follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in people with AN, that it will reduce measures of anxiety and depression, and that it will lead to increased quality of life. The investigators will also assess a number of exploratory measures related to eating disorder pathophysiology.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently meet criteria for AN restricting subtype by Diagnostic and Statistical Manual 5th edition (DSM-5) criteria, and have a history of AN for at least 3 years prior to screening
- •Have at least one prior attempt at treatment
- •Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (complete blood count, comprehensive metabolic panel, urine pregnancy test, urine toxicology screen).
- •Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.
排除标准
- •Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of childbearing potential and sexually active who are not practicing an effective means of birth control.
- •Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, heart valve, or transient ischemic attack in the past year. Resting heart rate may be no less than 50 beats per minute unless cleared by a cardiologist.
- •Epilepsy with history of seizures
- •Type 1 diabetes
- •First degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder
- •Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
研究组 & 干预措施
Experimental psilocybin
Participants will have up to four doses of psilocybin.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS)
时间窗: 2 months post final psilocybin session
This is a 40-item self-report measure of health related quality of life that is specifically developed for eating disorder populations. Each question is rated on a 5 point scale from 1-5, with higher scores indicating better quality of life.
Change in Hospital Anxiety and Depression Scale (HADS) Score
时间窗: 1 week post final psilocybin session
The HADS is a 14-item self-report questionnaire that assesses both anxiety (7 questions) and depression (7 questions). Each question is scored on a 4-point Likert scale from 0-3, with higher scores indicating more severe symptoms.
次要结局
- Change in Eating Disorder Examination Questionnaire (EDE-Q) score(1 month post final psilocybin session)
- Change in Eating Disorder Examination (EDE) score(1 month post final psilocybin session)
- Change in Body mass index (BMI)(3 months post final psilocybin session)
- Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score(1 month post final psilocybin session)