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
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
16
Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
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.
Pfizer Investigational Site
Hialeah, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score
Time frame: Week 6
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Time frame: Week 6
Weekly change in the PDSS-A total score
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and endpoint change from baseline in CGI-lmprovement scale
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Weekly change and and endpoint change from baseline in PDSS-A item scores
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Endpoint change from baseline in the Hamilton anxiety rating scale total score
Time frame: Week 6
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score
Time frame: Week 6
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire
Time frame: Week 6
Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit
Time frame: Baseline and Week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pfizer Investigational Site
North Miami, Florida, United States
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Terre Haute, Indiana, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Saint Paul, Minnesota, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Lyndhurst, Ohio, United States
...and 8 more locations
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)
Time frame: Baseline and Week 6
Population pharmacokinetic analysis
Time frame: Weeks 2, 4, and 6
Vital signs
Time frame: Weeks 1, 2, 3, 4, 5, and 6