临床试验/NCT07747324

NCT07747324招募中1 期

Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial

University of Sao Paulo1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2026年7月1日最近更新: 2026年8月5日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: University of Sao Paulo
入组人数: 15
试验地点: 1
主要终点: Seizure frequency

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Open label intervention with a single dose of ayahuasca in patients with psychogenic non-epileptic seizures (PNES)

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients aged 18 to 60 with documented PNES (confirmed via VEEG), without a diagnosis of comorbid epilepsy, and currently receiving follow-up care at outpatient clinics. To enroll in the study, patients must undergo a gradual reduction and discontinuation of any psychotropic medications (antidepressants, antipsychotics, benzodiazepines, or mood stabilizers/anticonvulsants) they are currently taking, in order to avoid drug interactions with-or influence on-the effects of ayahuasca.

排除标准

•Patients who have not experienced psychogenic seizures in the last 3 months; patients diagnosed with epilepsy; patients who refuse to reduce or discontinue their current psychotropic medications; patients with a history of prior ayahuasca use; patients with a history of substance use disorder; patients who refuse to sign the Informed Consent Form; patients with schizophrenia or other psychotic disorders and/or impaired reality testing; and pregnant or breastfeeding women.

研究组 & 干预措施

Ayahuasca

Experimental

single oral dose of ayahuasca (1 ml/kg)

干预措施: Ayahuasca (Drug)

结局指标

主要结局

Seizure frequency

时间窗: Baseline, 1, 2, 3 e 4 weeks

Seizure frequency

时间窗: Baseline, 1, 2, 3 and 4 weeks

Seizure frequency

次要结局

未报告次要终点

研究者

发起方

University of Sao Paulo

申办方类型

Other

责任方

Principal Investigator

主要研究者

Rafael Guimarães dos Santos

PhD, Professor

University of Sao Paulo

研究点 (1)

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