跳至主要内容
临床试验/NCT06557239
NCT06557239已完成不适用

Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy for Anxiety and Depression: a Pilot Study

Tatiana Aboulafia Brakha1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Salivary oxytocin

研究概览

简要总结

The main objective of this pilot study is to obtain preliminary data on the reactivity of salivary oxytocin during a single LSD intake as part of PAP treatment for anxiety disorders or depression (treatment authorisations granted in advance by the Federal Officie of Public Health for compassionate use of the substance).

There will be no interference with the usual clinical routine in our Service. The protocol is only for taking additional saliva measurements to measure oxytocin levels on the day of treatment.

Participants will be asked to give 4 saliva samples the day of their LSD treatment .In addition they will fill-in self-report questionnaires which are part of the clinical routine

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ongoing psychotherapy with a certified psychotherapist, anxiety disorder or depression resistant to usual treatments, agreement to stop necessary medication

排除标准

  • Exclusion: psychotic or bipolar disorder, high suicidal risk, severe cardiovascular disease, severe liver disease, neurological disease of the central nervous system, pregnancy and breastfeeding

结局指标

主要结局

Salivary oxytocin

时间窗: the day of treatment administration (one day)

oxytocin sampled in the saliva

次要结局

  • Self-reported symptoms of anxiety (STAI-T)(over 6 months)
  • Self-reported depressive symptoms (BDI-II)(over 6 months)
  • Self-reported intensity of mystical experience(The 1 day of treatment administration)
  • Self-reported intensity of Connectedness(The 1 day of treatment administration)

研究者

发起方
Tatiana Aboulafia Brakha
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tatiana Aboulafia Brakha

Principal Investigator-Head of psychologists

University of Geneva, Switzerland

研究点 (1)

Loading locations...

相似试验