NCT05481736已完成2 期
Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Change from baseline in the Eating Disorder Examination (EDE) global score
研究概览
简要总结
Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study
详细描述
This study aims to explore the efficacy and safety of COMP360 25 mg as compared to COMP360 1 mg (control condition) administered with psychological support in participants with Anorexia Nervosa
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Any sex and aged 18 years or above at screening.
- •Meeting criteria for AN either restrictive or binge-purging type, according to the DSM-5, based on medical records, clinical assessment, BMI, and documented completion of MINI 7.0.2 and EDE at screening.
- •Have successfully discontinued all prohibited medications for a period of at least two weeks prior to baseline. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of washout will be required prior to baseline.
- •Has a history of disordered eating with duration of at least 3 years prior to screening, that is consistent with AN.
- •BMI ≥15 kg/m2 and ≤20 kg/m
- •For participants with a BMI <16 kg/m2 and >18.5 kg/m2 at screening, approval from the Medical Monitor will be required. Any participant with a BMI >18.5 kg/m2 must meet all of the criteria for AN except that, despite significant weight loss, the individual's weight is within or above the normal range.
- •Being otherwise medically stable at screening determined by clinical interview, clinical laboratory values, vital signs, ECG, and medical history.
- •Have at least one documented prior attempt at treatment in the past 3 years.
排除标准
- •Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (MINI 7.0.2).
- •Prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder based on medical history and clinical judgment.
- •Borderline personality disorder as demonstrated by medical history, the MINI Plus - BPD and clinical judgment.
- •Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at screening or at baseline, or; (2) suicidal behaviours within the past year or; (3) clinical assessment of significant suicidal risk during participant interview.
- •Current (within last year) alcohol or substance use disorder as informed by the DSM-5 assessed via the MINI 7.0.2, and urine toxicology at screening.
- •Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
- •Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within the past year.
研究组 & 干预措施
25 mg COMP360 Psilocybin
Experimental
25 mg COMP360 Psilocybin
干预措施: Psilocybin (Drug)
1 mg COMP360 Psilocybin
Active Comparator
1 mg COMP360 Psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
Change from baseline in the Eating Disorder Examination (EDE) global score
时间窗: Week 4
The EDE is a structured clinical interview (investigator rated) used to measure severity of the characteristic psychopathology of eating disorders
次要结局
- Safety(Up to 12 weeks)
- Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(Week 4)
- Change from baseline in weight(Up to 12 weeks)
研究者
研究点 (5)
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