Pittsburgh, Pennsylvania 15260

  • Panic Disorder

Purpose:

OBJECTIVES: I. Determine whether the prevalence of abnormalities on clinical vestibular (balance) tests is higher in panic disorder with agoraphobia than in uncomplicated panic disorder and nonpanic anxiety disorder. II. Determine whether the prevalence of abnormalities on audiological tests of cochlear or brainstem function is elevated in panic disorder without agoraphobia or nonpanic anxiety disorder. III. Determine whether symptom patterns can be identified that are indicative of vestibular abnormalities in panic disorder. IV. Determine whether vestibular dysfunction can be induced by psychosomatic mechanisms.


Study summary:

PROTOCOL OUTLINE: Patients are stratified by otoneurological function (panic disorder without agoraphobia, panic disorder with agoraphobia, anxiety disorder without panic or agoraphobia-like avoidance, and normal controls). Patients undergo a psychiatric interview and a structured interview focused on anxiety disorders. Physical evaluation is completed. A vestibular evaluation consisting of posturography, rotational testing, and ocular motor screening battery, and positional and caloric testing is completed on all patients. Patients then complete an audiological test battery consisting of basic audiological analysis, speech recognition scores, immittance testing, brainstem evoked response, and determination of binaural masking level differences. Control patients also complete a hyperventilation-rotational test.


Criteria:

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnostically proven panic disorders with or without moderate or severe agoraphobia and anxiety disorders without panic or agoraphobia Panic disorder may be accompanied by a secondary Axis 1 diagnosis of another disorder, such as depression, generalized anxiety disorder, or dependent, histrionic, or compulsive personality disorder --Prior/Concurrent Therapy-- Surgery: No prior ear surgery Other: No concurrent medication for medical or psychiatric conditions At least 2 weeks since prior medication No ototoxic drug intake --Patient Characteristics-- No medical disorders At least 2 weeks since prior upper respiratory tract infection and recovered No history of migraine No head trauma No scoliosis No alcoholism No drug abuse No family history of schizophrenia


Study is Available At:


Original ID:

199/11945


NCT ID:

NCT00004367


Secondary ID:

UPITTS-9504279605


Study Acronym:


Brief Title:

Vestibular Dysfunction In Adult Patients With Panic Disorder With or Without Agoraphobia


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Research Resources (NCRR)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Diagnostic


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

165


Enrollment Type:


Overall Contact Information

Official Name:Rolf G. Jacob
Study Chair
University of Pittsburgh

Study Dates

Start Date:May 2000
Verification Date:December 2003
Last Changed Date:June 23, 2005
First Received Date:October 18, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Procedure
Name:Clinical vestibular tests

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Research Resources (NCRR)
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Pittsburgh

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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