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NCT00004367 Clinical Trial

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

Panic Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004367
Other study ID # 199/11945
Secondary ID UPITTS-950427960
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date May 2000

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Clinical vestibular tests

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Pittsburgh

Country where clinical trial is conducted

United States, 

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