A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

• Status: Terminated
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Alprazolam

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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