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临床试验/NCT05962424
NCT05962424招募中1 期

HNC: Human Neural Circuits Electrophysiology During Cognition

Stanford University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
120
试验地点
2
主要终点
Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)

研究概览

简要总结

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

详细描述

The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during antidepressant therapy and the side effect of dissociation. This research is designed to probe altered cognitive states associated with dissociation, depression, and other neuropsychiatric conditions.

研究设计

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

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

  • Patient in clinical neuro inpatient units at Stanford Medical Center
  • Age >18 years old
  • Female participants are expected to use an effective method of birth control throughout the study which includes: hormonal methods (birth control pills, patches, injections, vaginal ring or implants), barrier methods (condom or diaphragm) used with spermicide, intrauterine device (IUD), or abstinence (no sex)

排除标准

  • Lifetime psychotic disorder
  • Pregnant or nursing females
  • Prior adverse ketamine response
  • Use of ketamine in past 7 days

研究组 & 干预措施

Ketamine

Experimental

Study participants will receive 0.5mg/kg of ketamine - one single infusion

干预措施: Ketamine Hydrochloride (Drug)

结局指标

主要结局

Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)

时间窗: up to 1 week

The CADSS is an instrument for the measurement of dissociative symptoms. The CADSS comprises 23 subjective items and participant's responses are coded on a 5-point scale (0 = Not at all; 4 = Extreme). The higher the number on the CADSS, the more severe the symptoms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karl Deisseroth

Professor

Stanford University

研究点 (2)

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