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NCT01059227 · ClinicalTrials.gov registry record
Effects of a CRF1 Receptor Antagonist on Human Startle in Normal Female Volunteers
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 39
- Enrollment target
NCT01059227 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 39 participants.
The verdict
NCT01059227 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 39 participants
- Enrollment target
Study 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 cente
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2010-01-22 |
| Est. Completion | 2015-08-14 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01059227
The ClinicalTrials.gov registry entry for NCT01059227 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01059227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01059227 about?
NCT01059227 is a clinical study titled "Effects of a CRF1 Receptor Antagonist on Human Startle in Normal Female Volunteers". 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. Re...
What is the current status of trial NCT01059227?
This trial is currently completed. The enrollment target is 39 participants. The study started on 2010-01-22. Estimated completion is 2015-08-14.
Who is sponsoring clinical trial NCT01059227?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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