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临床试验/ACTRN12619001225101
ACTRN12619001225101已完成2 期

Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness

St. Vincent's Hospital Melbourne0 个研究点目标入组 35 人开始时间: 2019年9月5日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
35

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
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 85 Years(—)
性别
All

入选标准

  • Adults aged between 18-85 years with a life - threatening illness, under the care of a specialist physician; proficient in English (funds available for this research would preclude access to translators to enable non-English speaking participants); Experiencing psychological distress that was precipitate or augmented by their life-threatening illness; AKPS of 50 or above (or if participant is immobile but deemed physically well enough to participate by the study doctor and their treating physician, scores lower than 50; upon receipt of medial clearance from the potential participants primary treating physician and being screened by the study doctor and being deemed eligible.
  • Examples of eligible conditions include metastatic malignant diseases, end stage respiratory disease, end stage renal failure, incurable but indolent cancers that have a high likelihood of returning.

排除标准

  • Diseases with major CNS involvement
  • Hepatic dysfunction
  • Known paraneoplastic syndrome or ectopic hormone production
  • Uncontrolled cardiovascular condtions, unstable angina, atrial fibrillation, TIA
  • Patients who are respirator dependent or intubated.
  • A diagnosis of epilepsy or known previous seizure activity
  • Renal insufficiency
  • Insulin dependent diabetes
  • Females who are pregnant, nursing, or attempting to become pregnant
  • Patients taking SSRI or SNRI (participant may be eligible if they would like to wean and cease under supervision and if deemed safe to do so)
  • Participants taking medications including:
  • Rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, paclitaxol, St John's Wort, - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.
  • PSYCHIATRIC - Severity of depression or anxiety symptoms that would warrant immediate hospitalisation (including acute suicidality); current or past history of psychosis/psychotic disorder, current or past history of bipolar disorder; first degree relative with psychosis or bipolar disorder; current or past history of alcohol or substance dependence (excluding caffeine or nicotine) in the past 5 years; Axis II conditions that may not e compatible with the treatment protocol (determined by clinical interview).

研究者

发起方
St. Vincent's Hospital Melbourne

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