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.
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
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
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.
Pfizer Investigational Site
Eugene, Oregon, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Middleton, Wisconsin, United States
Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
Time frame: 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
Time frame: Weeks 6, 8, 12, 16, 20, and 24
Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
Time frame: Week 24
Endpoint change from baseline in Hamilton Anxiety Rating scale
Time frame: Weeks 12 and 24
Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores
Time frame: Weeks 12 an 24
Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale
Time frame: Weeks 12 and 24
Endpoint change compared with baseline in CGI-Severity score
Time frame: Weeks 12 and 24
Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Time frame: Weeks 12 and 24
Descriptive estimates of the persistence of safety events and adverse events
Time frame: Week 24
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