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
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