Effects of a CRF1 Receptor Antagonist on Human Startle in Normal Female Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Magnitude of the startle reflex
研究概览
简要总结
Background:
- Research has shown that the hormone corticotropin-releasing hormone (CRH) is involved in stress and anxiety, and that drugs that block the effect of CRH in the body can reduce anxiety. GSK561679 is an experimental drug that attempts to reduce anxiety by blocking the effect of CRH. Researchers are interested in comparing GSK561679 with other treatments for anxiety.
Objectives:
- To determine the effectiveness of GSK561679 compared with placebo and alprazolam (Xanax), as a possible treatment for fear and anxiety.
Eligibility:
- Healthy female volunteers between 21 and 50 years of age.
Design:
- This study will involve one screening visit, four testing visits, and one follow-up visit over a period of 8-9 weeks. The testing sessions will be between 6-11 days apart.
- Participants must follow these dietary restrictions to participate in the study.
- No nicotine, alcohol, or caffeine (including chocolate and soft drinks) for 24 hours before the start of the study.
- No nicotine in the past 6 months, and no nicotine until the final blood sample is collected at the follow-up visit.
- No alcohol or caffeine for 24 hours before a testing visit or for 72 hours after each visit.
- No grapefruit or grapefruit products from 14 days before the first dose of study medication until collection of the final blood sample.
- Participants will receive a dose of GSK561679, alprazolam, or placebo 3 hours before the testing, and will take an additional pill 1 hour before the testing.
- During the tests, participants will receive brief electric shocks and hear sudden loud noises. The noises and shocks will be given over a period of approximately 40 minutes per session.
- Skin conduction, heart rate, and blinking will be monitored throughout the tests, and participants will be asked about anxiety levels and will be tested on mood, memory, and concentration. Blood and saliva samples will also be taken during these sessions.
- Participants will stay in the clinical center for 1 to 2 hours after the study testing to ensure that the sedation has worn off. Participants will not be allowed to drive home or take public transportation alone after study visits, so alternative transportation must be arranged.
详细描述
Objective
This proposal is a part of an integrated project to test the efficacy of a candidate anxiolytic, a CRF1 receptor antagonist, provided by GlaxoSmithKline (GSK) as part of The Emory-MSSM-GSK-NIMH Collaborative Mood Disorders Initiative, using fear-potentiated startle. The anti-fear and anxiolytic activity of a single dose of the highly specific CRF1 antagonist GSK561679 will be evaluated in healthy female subjects using models of phasic (fear) and sustained (anxiety) aversive states derived from humans and from pre-clinical studies in rodents.
Study population: The study population will consist of 30 healthy female volunteers, 21-50 years of age, and of diverse racial and ethnic backgrounds.
Design: The study will use a double-blind cross-over design in which each subject will receive placebo, Alprazolam (1 mg), and a low (50 mg) and high (400 mg) dose of GSK561679. We will examine the effect of these drugs on the potentiation of startle during anticipation of no-shock, predictable shock signaled by a discrete threat cue, and unpredictable shock.
Outcome measures: The main outcome measures are the magnitude of the startle reflex and retrospective anxiety during each condition. Secondary measures will include the skin conductance response and changes in heart rate, as well as measures of HPA activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Magnitude of the startle reflex
时间窗: One year
次要结局
- Skin conductance response and heart rate(One year)