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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Panic Disorder

Intervention / Treatment
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* Other: placebo
* Drug: alprazolam XR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br> | Other: placebo<br>* Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam<br>|
| Active Comparator: Alprazolam XR group<br> | Drug: alprazolam XR<br>* Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period.<br>* Other names: Xanax XR;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly change in the PDSS-A total score |  | Weeks 1, 2, 3, 4, 5, and 6 | 
| Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale |  | 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 | 
| 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 the Hamilton anxiety rating scale total score |  | Week 6 | 
| Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score |  | Week 6 | 
| Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire |  | 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 | 
| Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test) |  | Baseline and Week 6 | 
| Population pharmacokinetic analysis |  | Weeks 2, 4, and 6 | 
| Vital signs |  | Weeks 1, 2, 3, 4, 5, and 6 |