EUCTR2019-004054-28-GB进行中（未招募）1 期
Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study - Panorexia V1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •DSM-V diagnosis of Anorexia Nervosa
- •>3 years of illness diagnosis
- •Current or past treatments have not been successful to maintain remission
- •21-65 years old
- •Be in the care of a specialist eating disorder team in the UK
- •Have a GP and/or specialist eating disorder team in the UK who can confirm diagnosis
- •Sufficiently competent in English and mental capacity to provide written informed consent
- •BMI >15kg/m2 and medically stable
- •Capacity to consent
- •Agree to have us maintain contact with an identified next-of-kin for the duration of the study
- •Agree to have us maintain contact with their specialist eating disorder team/care team as required for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Current or previously diagnosed psychotic disorder
- •Immediate family member with a diagnosed psychotic disorder
- •Unstable physical condition e.g., rapid weight loss > 2kg in the prior month
- •Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction
- •Medical condition that is unsuitable for the EEG components of the study (e.g., epilepsy, severe migraine)
- •Other physical conditions that are unsuitable for the psychedelic component of the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g., CrCl < 30ml/min etc)
- •MRI contraindications
- •Have a history of laxative abuse in the last 3 months (defined as laxative use more than twice a week for 3 months)
- •History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
- •Currently an involuntary patient
- •Significant history of mania (determined by study psychiatrist and medical records)
- •Emotionally unstable personality, or other psychiatric problem that the screening clinician feels may jeopardize the therapeutic alliance and/or safe exposure to psilocybin
- •Blood or needle phobia
- •Positive pregnancy test at screening or during the study, or woman who are breastfeeding
- •If sexually active, participants who lack appropriate contraceptive measures
- •Drug or alcohol dependence within the last 6 months
- •No email access
- •Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms)
- •Patients who are currently, or have recently (within 6 months) been enrolled in another CTIMP.
研究者
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