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临床试验/NCT01826786
NCT01826786已完成1 期

The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Subjects

Janssen Research & Development, LLC0 个研究点目标入组 43 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
43
主要终点
Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)

研究概览

简要总结

The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating anxiety disorders through evaluation of brain activation patterns using imaging technology in healthy volunteers.

详细描述

This is a single site, double-blind (neither investigator nor the participant knows the treatment that the participant receives) study. The study will consist of a screening phase (1-2 visits), a treatment phase (4 visits), and a post treatment phase (follow-up safety visit, 7 to 14 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria, which will include collection of blood and urine samples. During the treatment phase, eligible participants will be assigned by chance (like a toss of a coin) to receive either JNJ-42165279 100 mg or placebo once daily during 4 consecutive visits to the clinic. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The potential of the drug to treat anxiety will be assessed on Day 4 of the treatment phase. The primary assessment, Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI), will measure brain activity patterns while participants complete 3 emotionally-provoking tasks. Additionally, participants' startle responses (eye blinks) will be evaluated in two emotionally-provoking behavioral tasks outside of the scanner. Questionnaires will be completed to evaluate participants' mood, and blood samples will be collected to measure concentrations of JNJ-42165279 and biomarkers of drug activity.

Safety will be monitored throughout the study, including adverse events, vital signs (blood pressure and heart rate), 12-lead ECGs, physical examinations, clinical safety laboratories, evaluation of suicidal risk, and a Walk and Turn test. The total study duration will be approximately 46 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

JNJ-42165279 (100 mg)

Experimental

干预措施: JNJ-42165279 (100 mg) (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)

时间窗: Day 4

BOLD-fMRI percent signal changes during an Emotional Face Processing task.

次要结局

  • Startle response(Day 4)
  • Brain activity patterns in multiple areas of the emotional brain neurocircuitry(Day 4)
  • The number of volunteers who experience adverse events as a measure of safety and tolerability.(Day -28 to Day 18)

研究者

申办方类型
Industry
责任方
Sponsor

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