The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days.
Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall
Time frame: 24 weeks
Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam
Time frame: 6 week taper
The incidence of treatment-emergent adverse event during treatment with alprazolam XR
Time frame: 24 weeks with taper
Descriptive estimates of the persistence of safety events and adverse events at study endpoint
Time frame: 24 weeks with taper
Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores
Time frame: 24 weeks
Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score
Time frame: 24 weeks
Endpoint change from baseline to Week 24 in CGI-Severity score
Time frame: 24 weeks
Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Time frame: 24 weeks
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