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临床试验/NCT07345858
NCT07345858Enrolling By Invitation不适用

Salivary Oxytocin as a Biomarker of Psychedelic Assisted Psychotherapy in Patients With Major Depressive Disorder

University of Geneva, Switzerland1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
1
主要终点
Salivary Oxytocin

研究概览

简要总结

This study aims to investigate whether oxytocin reactivity during a psychedelic session for MDD treatment predicts treatment response, specifically by examining its relationship with changes in flexibility and depressive symptoms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18 years-old
  • MDD defined by DSM-V criteria, and resistant to treatment
  • Ongoing classical psychotherapeutic treatment
  • Agreement to discontinue necessary psychotropic medications (some classes of anti-depressants are allowed with no need to taper off).

排除标准

  • Psychotic or bipolar disorder
  • High suicidal risk
  • Severe cardiovascular, hepatic or neurological (affecting the central nervous system) disorders
  • Pregnancy or breastfeeding.

结局指标

主要结局

Salivary Oxytocin

时间窗: One day

Measure taken during psychedelic treatment

次要结局

  • Beck Depression Inventory(3 months)
  • Cognitive Flexibility Inventory(3 months)
  • Trait anxiety inventory (STAI-T)(3 months)
  • Cognitive Emotion Regulation Questionnaire (CERQ)(3 months)
  • Emotion Regulation Questionnaire(3 months)

研究者

发起方
University of Geneva, Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatiana Aboulafia Brakha

PhD

University of Geneva, Switzerland

研究点 (1)

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