NCT01059227

Effects of a CRF1 Receptor Antagonist on Human Startle in Normal Female Volunteers

Completed Last updated 5 July 2018

What this trial tests

trial in Anxiety Disorders in 39 participants. Completed in 14 August 2015.

Timeline

22 January 2010

14 August 2015

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	39
Start date	22 January 2010
Estimated completion	14 August 2015
Sites	1 location across United States

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

Adults 21 to 50, female only, with Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Behavioral, biological, and chemical perspectives on targeting CRF(1) receptor antagonists to treat alcoholism.
   Zorrilla EP, Heilig M, de Wit H, Shaham Y. · · 2013 · cited 83× · PMID 23294766 · DOI 10.1016/j.drugalcdep.2012.12.017
2. The CRF System as a Therapeutic Target for Neuropsychiatric Disorders.
   Sanders J, Nemeroff C. · · 2016 · cited 54× · PMID 27717506 · DOI 10.1016/j.tips.2016.09.004
3. Update on corticotropin-releasing factor pharmacotherapy for psychiatric disorders: a revisionist view.
   Koob GF, Zorrilla EP. · · 2012 · cited 39× · PMID 22157874 · DOI 10.1038/npp.2011.213
4. The CRH1 antagonist GSK561679 increases human fear but not anxiety as assessed by startle.
   Grillon C, Hale E, Lieberman L, Davis A, et al · · 2015 · cited 36× · PMID 25430779 · DOI 10.1038/npp.2014.316
5. Evaluation of a corticotropin releasing hormone type 1 receptor antagonist in women with posttraumatic stress disorder: study protocol for a randomized controlled trial.
   Dunlop BW, Rothbaum BO, Binder EB, Duncan E, et al · · 2014 · cited 32× · PMID 24950747 · DOI 10.1186/1745-6215-15-240