ISRCTN10441504已完成未知
Psilocybin as a treatment for anorexia nervosa: a pilot study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34744825/ (added 13/01/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 08/11/2022:
- •1. DSM-V primary diagnosis of Anorexia Nervosa
- •2. Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care team to have likely been present for >3 years
- •3. Current or past treatments have not been successful to maintain remission
- •4. 21 - 65 years old
- •6. Be in the care of a specialist eating disorder team in the UK
- •7. Have a GP and/or specialist eating disorder team in the UK who can confirm diagnosis
- •8. Sufficiently competent in English and mental capacity to provide written informed consent
- •9. BMI >14kg/m² and medically stable
- •10. Capacity to consent
- •11. Agree to have us maintain contact with an identified next-of-kin for the duration of the study
- •12. Agree to have us maintain contact with their specialist eating disorder team/care team as required for the duration of the study
- •Previous inclusion criteria:
- •1. DSM-V diagnosis of Anorexia Nervosa
- •2. >3 years of illness diagnosis
- •3. Current or past treatments have not been successful to maintain remission
- •4. 21 - 65 years old
- •6. Be in the care of a specialist eating disorder team in the UK
- •7. Have a GP and/or specialist eating disorder team in the UK who can confirm diagnosis
- •8. Sufficiently competent in English and mental capacity to provide written informed consent
- •9. BMI >15kg/m² and medically stable
- •10. Capacity to consent
- •11. Agree to have us maintain contact with an identified next-of-kin for the duration of the study
- •12. Agree to have us maintain contact with their specialist eating disorder team/care team as required for the duration of the study
排除标准
- •1. Current or previously diagnosed psychotic disorder
- •2. Immediate family member with a diagnosed psychotic disorder
- •3. Unstable physical condition e.g., rapid weight loss > 2kg in the prior month
- •4. Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction
- •5. Medical condition that is unsuitable for the EEG components of the study (e.g., epilepsy, severe migraine)
- •6. 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.)
- •7. MRI contraindications
- •8. Have a history of laxative abuse in the last 3 months (defined as laxative use more than twice a week for 3 months)
- •9. History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
- •10. Currently an involuntary patient
- •11. Significant history of mania (determined by study psychiatrist and medical records)
- •12. Emotionally unstable personality, or other psychiatric problem that the screening clinician feels may jeopardize the therapeutic alliance and/or safe exposure to psilocybin
- •13. Blood or needle phobia
- •14. Positive pregnancy test at screening or during the study, or woman who are breastfeeding
- •15. If sexually active, participants who lack appropriate contraceptive measures
- •16. Drug or alcohol dependence within the last 6 months
- •17. No email access
- •18. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms)
- •19. Patients who are currently, or have recently (within 6 months) been enrolled in another CTIMP
研究者
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