NCT00032838

Brief Summary

The purpose of this study is to examine how hormonal changes that occur during stressful situations affect thought and emotions. Results from this study may lead to treatments that can alleviate the psychological effects of trauma. Levels of cortisol and norepinephrine increase in response to stress; these hormones also influence thought processes. This study will give hydrocortisone and/or yohimbine (a stimulator of central norepinephrine) to healthy adults in order to model the stress response and to better understand the way people process information during traumatic events. This study comprises two experiments in which the stress response is pharmacologically modeled. Participants in the study will have two study visits. During Visit 1, participants will undergo a psychiatric assessment, complete neuropsychological tasks, and have their IQ measured. During Visit 2, participants will be given hydrocortisone and/or yohimbine. Blood will be collected before and during this. Participants will then perform two experiments. In one experiment, participants will hear a story with emotional and non-emotional segments; in a second experiment, participants will view both emotional and non-emotional stimuli.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

March 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2002

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2006

First QC Date

April 3, 2002

Last Update Submit

March 3, 2008

Conditions

Keywords

HydrocortisoneYohimbineCognitionNorepinephrineCortisolEmotionHealthy VolunteerHVNormal Control

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-36
  • IQ: all subjects will have IQ greater than 85
  • Follicular cycle: Women will participate in the encoding task between days 3-10.

You may not qualify if:

  • Pregnancy/Nursing
  • Only healthy individuals will participate; special attention will be taken to ensure that no subject has: hypertension, glaucoma, cataracts, ulcers, renal insufficiency, osteoporosis, hypothyroidism, cirrhosis, ocular herpes simplex and myocardial infarction.
  • Use of hormonal contraception
  • Use of glucocorticoids within past 3 years
  • Use of any psychoactive substance; current or past psychiatric diagnosis.
  • Irregular sleep pattern as defined as getting less than 6 hours of sleep per night, going to sleep after 2:00 AM; waking up before 5:00 AM or after 11:00 AM
  • Weight that is 15% more or less than ideal body weight for sex and height
  • History of panic attacks or first degree relative with history of panic attacks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Diamond DM, Fleshner M, Ingersoll N, Rose GM. Psychological stress impairs spatial working memory: relevance to electrophysiological studies of hippocampal function. Behav Neurosci. 1996 Aug;110(4):661-72. doi: 10.1037//0735-7044.110.4.661.

    PMID: 8864259BACKGROUND
  • Sandi C, Loscertales M, Guaza C. Experience-dependent facilitating effect of corticosterone on spatial memory formation in the water maze. Eur J Neurosci. 1997 Apr;9(4):637-42. doi: 10.1111/j.1460-9568.1997.tb01412.x.

    PMID: 9153570BACKGROUND
  • Christianson SA, Fallman L. The role of age on reactivity and memory for emotional pictures. Scand J Psychol. 1990;31(4):291-301. doi: 10.1111/j.1467-9450.1990.tb00841.x.

    PMID: 2274761BACKGROUND

MeSH Terms

Interventions

Yohimbine

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 3, 2002

First Posted

April 4, 2002

Study Start

March 1, 2002

Study Completion

January 1, 2006

Last Updated

March 4, 2008

Record last verified: 2006-01

Locations