Status:
TERMINATED
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Panic Disorder
Eligibility:
All Genders
13-17 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with panic disorder
Detailed Description
Due to recruitment difficulties in this adolescent population, the clinical program for alprazolam XR was cancelled and this study was terminated on 1 September 2004. There were no safety concerns tha...
Eligibility Criteria
Inclusion
- A primary DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents
- At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening
- At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline
- At least one 4-symptom panic attack in the 7 days prior to baseline
Exclusion
- Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence
- Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder
- Any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder
- A CDRS-R score \>35
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00635531
Start Date
April 1 2004
End Date
September 1 2004
Last Update
January 28 2021
Active Locations (18)
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1
Pfizer Investigational Site
Hialeah, Florida, United States, 33013
2
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
3
Pfizer Investigational Site
North Miami, Florida, United States, 33161
4
Pfizer Investigational Site
Boise, Idaho, United States, 83702