NCT00044096

Brief Summary

The purpose of this study is to understand the effects of the drug alprazolam (Xanax ) on anxiety. To understand the effect of anxiety-relieving drugs on fear and anxiety, researchers often have participants anticipate unpleasant stimuli. Anticipating unpleasant stimuli increases or potentiates a simple reflex called the startle reflex. The so-called fear-potentiated startle reflex (FPS) effect may be blocked or reduced by anxiety-relieving drugs. Evidence suggests that the FPS can be mediated by two mechanisms that regulate the phasic- and sustained enhancement of startle. This study will elicit phasic and sustained FPS in participants by having them anticipate moderately painful stimuli that are administered predictably and unpredictably. The main goal of this study is to assess the affect of alprazolam on the phasic and sustained enhancement of startle. This study comprises two pilot experiments and a main study. Participants in the study will be screened with a psychiatric history, physical examination, electrocardiogram (EKG), and blood and urine tests. Participants will four testing sessions separated by 5 to 10 days. At each session, participants will be given one of two doses of alprazolam, diphenhydramine, or placebo (an inactive pill). Questionnaires and other tests will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2002

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 16, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2002

Completed
11.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2013

Completed
Last Updated

July 5, 2018

Status Verified

September 17, 2013

First QC Date

August 16, 2002

Last Update Submit

July 3, 2018

Conditions

Healthy

Keywords

SSRIAnxietyStressCitalopramBenadrylDiphenhydramineStartleFear-Potentiated StartleFearNormal VolunteersHealthy VolunteersHV

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will be healthy volunteers between 18-45 years old and free of current psychopathology and organic central nervous system disorders.

You may not qualify if:

  • Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurologic illness, seizure, etc.)
  • Adverse reactions to cortisol (cortisol study only)
  • Adverse reactions to benzodiazepines or antihistamines (alprazolam study only)
  • History of angioedema
  • Osteoporosis (Hydrocortisone study only)
  • High or low blood pressure
  • History of fainting
  • First degree relative with history of mania, schizophrenia, or other psychoses
  • A history of mania, schizophrenia, or other psychoses
  • Current migraine
  • Use of herbal medicines or dietary supplements with psychoactive properties (citalopram study only)
  • Any current psychiatric disorders
  • Past alcohol/drug dependence and alcohol/drug abuse in past one year
  • Current use of psychotropic medication
  • Impaired hearing
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bitsios P, Philpott A, Langley RW, Bradshaw CM, Szabadi E. Comparison of the effects of diazepam on the fear-potentiated startle reflex and the fear-inhibited light reflex in man. J Psychopharmacol. 1999;13(3):226-34. doi: 10.1177/026988119901300303.

    PMID: 10512076BACKGROUND

  • Riba J, Rodriguez-Fornells A, Urbano G, Morte A, Antonijoan R, Barbanoj MJ. Differential effects of alprazolam on the baseline and fear-potentiated startle reflex in humans: a dose-response study. Psychopharmacology (Berl). 2001 Oct;157(4):358-67. doi: 10.1007/s002130100816.

    PMID: 11605094BACKGROUND

  • Davis M, Falls WA, Campeau S, Kim M. Fear-potentiated startle: a neural and pharmacological analysis. Behav Brain Res. 1993 Dec 20;58(1-2):175-98. doi: 10.1016/0166-4328(93)90102-v.

    PMID: 8136044BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Christian Grillon, Ph.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 16, 2002

First Posted

August 19, 2002

Study Start

August 15, 2002

Study Completion

September 17, 2013

Last Updated

July 5, 2018

Record last verified: 2013-09-17

Locations

US(1)