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

Phase 4

Terminated

• Conditions: Panic Disorder
• Interventions: Drug: alprazolam XR; Other: placebo

• Registration Number: NCT00635531
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Timeline

• Study Start: 2004-04
• Study Completion: 2004-09
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alprazolam XR group	alprazolam XR	-
Placebo group	placebo	-

Primary Outcome Measures

Name	Time	Method
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks	Week 6
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score	Week 6

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Middleton, Wisconsin, United States