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临床试验/ISRCTN10584863
ISRCTN10584863已完成2 期

Psilocybin versus escitalopram for major depressive disorder: comparative mechanisms

Imperial College Joint Research Compliance Office (JRCO)0 个研究点目标入组 59 人开始时间: 2018年9月10日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
59

研究概览

简要总结

2018 Interim results article in https://pubmed.ncbi.nlm.nih.gov/29119217/ (added 28/06/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33852780/ (added 28/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35411074/ Increased global integration in the brain after psilocybin therapy for depression (added 28/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35431912/ Therapeutic Alliance and Rapport Modulate Responses to Psilocybin Assisted Therapy for Depression (added 28/06/2022)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Major depressive disorder (DSM-IV)
  • 2. Depression of moderate to severe degree (17+ on the 21-item HAM-D).
  • 2. No MRI contraindications
  • 3. No SSRI contraindications
  • 4. Has a GP or other mental healthcare professional who can confirm diagnosis
  • 5. Aged 18-80
  • 6. Sufficiently competent with English language

排除标准

  • 1. Current or previously diagnosed psychotic disorder
  • 2. Immediate family member with a diagnosed psychotic disorder
  • 3. Medically significant condition rendering unsuitability for the study (e.g. diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. CLRC < 30 ml/min etc)
  • 4. History of serious suicide attempts requiring hospitalisation.
  • 5. Significant history of mania (determined by study psychiatrist and medical records)
  • 6. Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin (e.g. borderline personality disorder)
  • 7. Blood or needle phobia
  • 8. Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
  • 9. Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
  • 10. Current drug or alcohol dependence
  • 11. No email access
  • 12. Use of contraindicated medication
  • 13. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)

研究者

发起方
Imperial College Joint Research Compliance Office (JRCO)

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