NCT00046553

Completed

Brain Receptor Function in Post-Traumatic Stress Disorder

National Institute of Mental Health (NIMH)Source

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Other study identifiers

Sponsor study identifier

020317

Secondary identifiers

02-M-0317

Study Type

observational

Reported enrollment (type unavailable)

97

Locations

1 country

Sites

1

Timeline

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2004

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The purpose of this study is to examine the function of cortisol receptors in post-traumatic stress disorder (PTSD). Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased hippocampal volume are major features of the disorder. The mechanisms responsible for these alterations are not known. This study will evaluate the function of cortisol receptors to determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects will take part in the study: Patients with PTSD, healthy control subjects who were exposed to trauma in the past and remained healthy and healthy control subjects who were never traumatized At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the brain as well as eye blink trace conditioning and neuropsychological tests. Participants will be admitted to the Clinical Center for two nights on three different occasions. At each overnight visits, blood levels of stress hormones will be measured every hour for 26 hours after medication or placebo are given. This will be the end of the study for both groups of healthy control subjects, with the exception that they may be asked to repeat neuropsychologic and eye blink tests after 12 weeks. Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these participants will be reevaluated in exactly the same way as before treatment (except they will not repeat the MRI scan).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 97 participants
Study completion date: October 2004
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 30, 2002
Actual (reported)
First Posted
October 1, 2002
Actual (reported)
Study Completion
October 2004
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: March 4, 2008
Status Verified: October 2004
Last Update Submitted: March 3, 2008

Conditions

Post-Traumatic Stress Disorder

Keywords

CortisolCRHHPA AxisHypothalamusHippocampusPost-Traumatic Stress DisorderPTSDHealthy Volunteer

Interventions

RU-486 (Mifepristone)Drug

Eligibility Criteria

Sexall

Healthy VolunteersYes

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

You may qualify if:

to 65 years of age.
Male and female.

Sponsors & Collaborators

National Institute of Mental Health (NIMH)
NIHlead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Related Publications (3)

Yehuda R. Biology of posttraumatic stress disorder. J Clin Psychiatry. 2001;62 Suppl 17:41-6.
PMID: 11495096BACKGROUND
Gesing A, Bilang-Bleuel A, Droste SK, Linthorst AC, Holsboer F, Reul JM. Psychological stress increases hippocampal mineralocorticoid receptor levels: involvement of corticotropin-releasing hormone. J Neurosci. 2001 Jul 1;21(13):4822-9. doi: 10.1523/JNEUROSCI.21-13-04822.2001.
PMID: 11425909BACKGROUND
Bremner JD, Randall P, Scott TM, Bronen RA, Seibyl JP, Southwick SM, Delaney RC, McCarthy G, Charney DS, Innis RB. MRI-based measurement of hippocampal volume in patients with combat-related posttraumatic stress disorder. Am J Psychiatry. 1995 Jul;152(7):973-81. doi: 10.1176/ajp.152.7.973.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type: observational
Sponsor Type: NIH

Study Record Dates

First Submitted

September 30, 2002

First Posted

October 1, 2002

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

October 2004

Date type not reported

This date has not been verified as actual or estimated.

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Score greater than or equal to 50 on the Clinician-Administered PTSD Scale (CAPS-2) as a baseline measure of PTSD symptom severity.

Capable of providing informed consent, obtained prior to any study procedures.

Free of all psychotropic medication for at least 2 weeks, excluding short-term hypnotics. Patients who were treated with fluoxetine will only be included after a medication free period of at least 8 weeks.

You may not qualify if:

Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to screening. The effect of abuse/dependence on phenomenology and biology could mask and exceed PTSD effect.
Patients at current risk for homicide or suicide.
All additional DSM IV Axis I comorbidity, excluding secondary diagnoses of major depressive disorder (MDD) or anxiety disorder (AD). Given the high comorbidity of these disorders in PTSD, and since excluding such patients would not provide the full spectrum of the disorder, only patients in whom axis I diagnoses of MDD and AD preceded onset of PTSD will be excluded.
Pregnant women (all stages) and women of childbearing potential who are not practicing a clinically accepted method of contraception or who have a positive pregnancy test or who are lactating.
Blood donation (1 Red Cross Unit) within the 8 weeks preceding the study. This is the minimal safe period between consecutive donations.
Subjects who are doing well on medication. Although we will only recruit non-medicated patients, the decision to stop medication will be taken purely on clinical grounds. No subject will be taken off medication solely to participate in the study.
Unable to comply with study procedures or assessments as regards the screening evaluation (i.e. PTSD diagnosis, health requirements, etc.) and the 3 hospitalization for evaluation of glucocorticoid and mineralocorticoid receptor function.
Subjects who are allergic to mifepristone, paroxetine or spironolactone, and subjects with any contraindication to treatment with these agents (as described in their current labeling), will be excluded from participation in the study.

Contact the study team to confirm eligibility.

PMID: 7793467BACKGROUND

Last Updated

March 4, 2008

Record last verified: 2004-10

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00046553
Data provider: ClinicalTrials.gov
Source updated: 2008-03-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:35 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations