Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-02 @ 8:19 AM
Study NCT ID:
NCT01059227
Status:
COMPLETED
Last Update Posted:
2018-07-05
First Post:
2010-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a CRF1 Receptor Antagonist on Human Startle in Normal Female Volunteers
Sponsor:
National Institute of Mental Health (NIMH)
Organization:
Study Overview
Official Title:
Effects of a CRF1 Receptor Antagonist on Human Startle in Normal Female Volunteers
Status:
COMPLETED
Status Verified Date:
2015-08-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
\- 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-M-0049 | None | None | View |