NCT00025974

Completed

Brain Chemical Receptor Effects in Patients With Panic Disor...

National Institute of Mental Health (NIMH)Source

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Other study identifiers

Sponsor study identifier

020002

Secondary identifiers

02-M-0002

Study Type

observational

Reported enrollment (type unavailable)

230

Locations

1 country

Sites

1

Timeline

Study Start

October 31, 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 21, 2008

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The purpose of this study is to examine how certain brain chemicals work in patients with Panic Disorder (PD) and Post-Traumatic Stress Disorder (PTSD) with and without major depressive disorder (MDD). Brain chemicals that regulate emotion, anxiety, sleep, stress hormones, and other body functions bind to serotonin (5-HT1A) and benzodiazepine (BZD) receptors. Evidence suggests that 5-HT1A and BZD receptor function is abnormal in patients with PD, PTSD, and depression. This study will use positron emission tomography (PET) scans to examine BZD and 5-HT1A receptor binding potential in patients with PD and patients with PTSD with and without co-morbid MDD, as well as in healthy volunteers. This study will also determine the effects of the stress hormone cortisol on 5-HT1A and BZD receptors. The current emotional state and psychiatric, medical, and family history of potential participants will be evaluated during an initial telephone interview. After entering the study, participants will be asked questions about general mood, degree of nervousness, and behavior. A physical examination, an electrocardiogram (EKG), and tests of intelligence and cognition will be given. Urine, blood, and saliva samples will be taken. Women will be given pregnancy tests and tests to determine menstrual phase and time of ovulation. All volunteers will undergo magnetic resonance imaging (MRI) and PET scans of the brain. ...

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): 230 participants
Study completion date: July 21, 2008
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
October 31, 2001
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 2, 2001
Actual (reported)
First Posted
November 5, 2001
Actual (reported)
Study Completion
July 21, 2008
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: July 2, 2017
Status Verified: July 21, 2008
Last Update Submitted: June 30, 2017

Conditions

Major Depressive Disorder Panic Disorder Posttraumatic Stress Disorder

Keywords

PET5-HT1A ReceptorsBenzodiazepine ReceptorsPanic DisorderPTSDSerotonin Type 1A ReceptorsPost-Traumatic Stress DisorderMajor DepressionAnxietyDepressionHealthy VolunteerHVNormal Control

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

ANXIETY DISORDERS SAMPLES:
Eighty four subjects (ages 18-50) with anxiety disorders (PD and PTSD) will be selected who additionally meet criteria for one of 4 subgroups:

Sponsors & Collaborators

National Institute of Mental Health (NIMH)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Related Publications (3)

Azmitia EC, Whitaker-Azmitia PM. Awakening the sleeping giant: anatomy and plasticity of the brain serotonergic system. J Clin Psychiatry. 1991 Dec;52 Suppl:4-16.
PMID: 1752858BACKGROUND
Sprouse JS, Aghajanian GK. Responses of hippocampal pyramidal cells to putative serotonin 5-HT1A and 5-HT1B agonists: a comparative study with dorsal raphe neurons. Neuropharmacology. 1988 Jul;27(7):707-15. doi: 10.1016/0028-3908(88)90079-2.
PMID: 2901680BACKGROUND

MeSH Terms

Conditions

Panic DisorderStress Disorders, Post-TraumaticDepressive Disorder, MajorAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersDepressive DisorderMood DisordersBehavioral SymptomsBehavior

Study Design

Study Type: observational
Sponsor Type: NIH

Study Record Dates

First Submitted

November 2, 2001

First Posted

November 5, 2001

Study Start

October 31, 2001

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 21, 2008

Date type not reported

This date has not been verified as actual or estimated.

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Not ApplicableCompleted

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A) PD, Currently Depressed (n=27):

As defined by DSM-IV criteria for PD, and still symptomatic as defined by at least 1 panic attack/week or a CGI score of at least 4, and current HDRS score in the mild-moderately-to-severely depressed range (greater than 15).

Patients are requested to meet the DSM-IV criteria for a single or recurrent episode of major depressive disorder.

In case of comorbid depression it will be ensured that PD had an earlier onset than the depressive disorder.

B) PD, Currently Not Depressed (n=27):

Defined as having symptomatic PD with at least 1 panic attack/week or a CGI score of at least 4 and never having had experienced a depressive episode meeting DSM-IV criteria for major depressive disorder or dysthymia, OR a period of at least six months with no more than one clinically significant symptom, and during which time subjects were not taking an AD agent, with Hamilton Depression Rating Scale (HDRS; 25 item) scores in the non-depressed range (less than or equal to 7) will be selected.

C) PTSD, Currently Depressed (n=15):

As defined by DSM-IV with a duration of illness at least three months.

Patients must score greater than or equal to 50 on Clinician-Administered PTSD Scale (CAPS-2) as a measure of PTSD symptom severity.

Patients are requested to meet the DSM-IV criteria for a single or recurrent episode of major depressive disorder.

Current HDRS score is in the mild-moderately-to-severely depressed range (greater than or equal to 15).

In case of comorbid depression it will be ensured that PTSD had an earlier onset than the depressive disorder.

D) PTSD, Currently Not Depressed (n=15):

+7 more criteria

You may not qualify if:

Patients and controls must exhibit no or only moderate alcohol use.
Subjects with current or previous regular (greater than 4 weeks) of BZDs and excessive use of alcohol (greater than 8 ounce/day for men and greater than six ounces /day for women) in the past or present are ineligible to participate, as they may produce a down-regulation of the BZD receptor that may confound the results.
Postmenopausal female subjects.
Subjects beyond age 50 are excluded to reduce the biological heterogeneity encompassed by the MDD and anxiety disorders criteria.
Subjects whose first anxiety disorder episode arose temporally after other major medical or psychiatric conditions will also be excluded.
In addition to the above criteria, subjects undergoing the serotonin transporter scan will also be excluded if they have taken the recreational drug ecstasy within 3 weeks prior to scan or for regular use in the past.

Contact the study team to confirm eligibility.

Chaput Y, de Montigny C. Effects of the 5-hydroxytryptamine receptor antagonist, BMY 7378, on 5-hydroxytryptamine neurotransmission: electrophysiological studies in the rat central nervous system. J Pharmacol Exp Ther. 1988 Jul;246(1):359-70.

PMID: 2839669BACKGROUND

Last Updated

July 2, 2017

Record last verified: 2008-07-21

Source record

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Registry identifier: NCT00025974
Data provider: ClinicalTrials.gov
Source updated: 2017-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:21 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

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations