临床试验/NCT00700076

NCT00700076已完成1 期

Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects

Yale University1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2008年1月22日最近更新: 2022年3月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Yale University
入组人数: 15
试验地点: 1
主要终点: Attenuation of ketamine-induced cognitive deficits by Org 25935

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

Org 25935 is a new putative antipsychotic agent developed by N.V. Organon.The primary objective of this study is to investigate the effect of Org 25935 on ketamine-induced impairments in immediate recall.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Male, 18 - 55 years

排除标准

•History of sensitivity/idiosyncrasy to the drugs used in the study or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past.

研究组 & 干预措施

2

Placebo Comparator

干预措施: Placebo and Ketamine (Drug)

1

Active Comparator

干预措施: Ketamine and Org 25935 (Drug)

结局指标

主要结局

Attenuation of ketamine-induced cognitive deficits by Org 25935

时间窗: +20 to +100 minutes

次要结局

Attenuation of ketamine-induced schizophrenia-like psychotic symptoms, perceptual alterations, subjective high and deficits in attention and working memory by Org 25935.(0 to +100 minutes)
Investigation of interaction of polymorphisms of candidate genes e.g., BDNF, COMT with the effect of Org 25935 on ketamine induced psychotomimetic and amnestic deficits.(0 to +100 minutes)

研究者

发起方

Yale University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Deepak C. D'Souza

Associate Professor

Yale University

研究点 (1)

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