A Randomized, Double-blind, Placebo-controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country16 target enrollmentApril 2004

ConditionsPanic Disorder

Interventionsplacebo alprazolam XR

Drugsalprazolam XR

Overview

Phase: Phase 4
Intervention: placebo
Conditions: Panic Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 16
Locations: 1
Primary Endpoint: Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 that led to this decision.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

September 2004

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Placebo group

Intervention: placebo

Alprazolam XR group

Intervention: alprazolam XR

Outcomes

Primary Outcomes

Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks

Time Frame: Week 6

Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score

Time Frame: Week 6

Secondary Outcomes

Endpoint change from baseline in the Hamilton anxiety rating scale total score(Week 6)
Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit(Baseline and Week 6)
Population pharmacokinetic analysis(Weeks 2, 4, and 6)
Weekly change and and endpoint change from baseline in PDSS-A item scores(Weeks 1, 2, 3, 4, 5, and 6)
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire(Week 6)
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale(Weeks 1, 2, 3, 4, 5, and 6)
Vital signs(Weeks 1, 2, 3, 4, 5, and 6)
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score(Week 6)
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)(Baseline and Week 6)
Weekly change in the PDSS-A total score(Weeks 1, 2, 3, 4, 5, and 6)
Weekly change and endpoint change from baseline in CGI-lmprovement scale(Weeks 1, 2, 3, 4, 5, and 6)