NCT00635076TerminatedPhase 4
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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country3 target enrollmentStarted: July 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo group
Placebo Comparator
Intervention: placebo (Other)
Alprazolam XR group
Active Comparator
Intervention: alprazolam XR (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Endpoint change from baseline in Hamilton Anxiety Rating scale(Weeks 12 and 24)
- Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement 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 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)
Investigators
Study Sites (1)
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