ACTRN12623000357651尚未招募1 期
A clinical trial to assess safety and efficacy of psilocybin-assisted psychotherapy for treatment-resistant anorexia nervosa in adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 65 Years（—）
- 性别
- Female
入选标准
- •Female patients aged 21+ years
- •Meet criteria for AN as per DSM-5 criteria
- •BMI greater than or equal to 14kg/m2
- •> 3 years of illness duration
- •Current/ past treatments have not maintained remission
- •Referral from care team (psychiatrist or GP and clinician)
- •Agree to maintain contact with their care team
- •Identified support person
- •Agree to refrain from psychoactive drugs, nutritional or herbal supplements for at least 24 hours before each dose of psilocybin
- •Agree to a washout serotonergic medications if currently prescribed
- •Availability for the duration of the study
- •Agree to have research team maintain contact with an identified next-of-kin or support person (i.e. close friend) for the duration of the study
- •Capacity to consent
- •Sufficiently competent in English and mental capacity to provide written informed consent.
排除标准
- •History of neurological conditions (e.g. epilepsy)
- •Schizophrenia or other psychotic disorders/bipolar disorder
- •First or second degree relative with psychotic disorder
- •Severe dissociative disorders e.g.
- •Cardiovascular disease
- •Uncorrected hypo- or hyperthyroidism
- •Abnormal serum electrolytes
- •Raised cardiac enzymes
- •Abnormal QT interval prolongation at screening or history of this
- •Hypertension
- •Hepatic or renal failure (e.g., CrCl < 30ml/min)
- •Drug or alcohol dependence in last 6 months
- •Prior allergy, hypersensitivity or adverse reaction to psychedelic substances
- •Emotionally unstable personality, or other psychiatric problem that may jeopardize therapeutic alliance or safety
- •Currently an involuntary patient
- •Patient being unsafe to manage on an outpatient basis
- •History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
- •History of laxative abuse in the last 3 months
- •Unstable physical condition (e.g., weight loss > 2 kg in the prior month)
- •Pregnancy (negative pregnancy tests mandatory at screening visits, baseline, and psilocybin dosing sessions) or Nursing
- •If sexually active, participants who lack appropriate contraception
- •Patients currently or previously (past 3 months) enrolled in another clinical trial of an investigational product
- •No email/phone.
研究者
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