A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) 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 long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in 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 Continuation Treatment With 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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of panic disorder with or without agoraphobia based on the Mini-International Neuropsychiatric Interview for Children and Adolescents Subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline To enter Study A6131007, subjects must have completed Study A6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment. Exclusion Criteria: Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.

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>* Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).<br>|
| Active Comparator: Alprazolam XR group<br> | Drug: alprazolam XR<br>* Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced.<br>* Other names: Xanax XR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam |  | Week 24 (taper baseline), Weeks 25-29, and end of taper visit | 
| The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR |  | Weeks 6, 8, 12, 16, 20, and 24 | 
| Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoint change from baseline in Hamilton Anxiety Rating scale |  | Weeks 12 and 24 | 
| Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores |  | Weeks 12 an 24 | 
| Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale |  | Weeks 12 and 24 | 
| Endpoint change compared with baseline in CGI-Severity score |  | Weeks 12 and 24 | 
| Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score |  | Weeks 12 and 24 | 
| Descriptive estimates of the persistence of safety events and adverse events |  | Week 24 |