Vestibular Dysfunction In Adult Patients With Panic Disorder With or Without Agoraphobia
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|ClinicalTrials.gov Identifier: NCT00004367|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
|First Submitted Date ICMJE||October 18, 1999|
|First Posted Date ICMJE||October 19, 1999|
|Last Update Posted Date||June 24, 2005|
|Study Start Date ICMJE||May 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vestibular Dysfunction In Adult Patients With Panic Disorder With or Without Agoraphobia|
|Official Title ICMJE||Not Provided|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Primary Purpose: Diagnostic|
|Intervention ICMJE||Procedure: Clinical vestibular tests|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00004367|
|Other Study ID Numbers ICMJE||199/11945
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Center for Research Resources (NCRR)|
|Collaborators ICMJE||University of Pittsburgh|
|PRS Account||National Center for Research Resources (NCRR)|
|Verification Date||December 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP