NCT00635531TerminatedPhase 4
A Randomized, Double-blind, Placebo-controlled Study of 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 country16 target enrollmentStarted: April 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Study Overview
Brief Summary
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
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 DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents
- •At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening
- •At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline
- •At least one 4-symptom panic attack in the 7 days prior to baseline
Exclusion Criteria
- •Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence
- •Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder
- •Any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder
- •A CDRS-R score >35
Arms & Interventions
Placebo group
Placebo Comparator
Intervention: placebo (Other)
Alprazolam XR group
Active Comparator
Intervention: alprazolam XR (Drug)
Outcomes
Primary Outcomes
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Time Frame: Week 6
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score
Time Frame: Week 6
Secondary Outcomes
- Endpoint change from baseline in the Hamilton anxiety rating scale total score(Week 6)
- Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit(Baseline and Week 6)
- Population pharmacokinetic analysis(Weeks 2, 4, and 6)
- Weekly change and and endpoint change from baseline in PDSS-A item scores(Weeks 1, 2, 3, 4, 5, and 6)
- Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire(Week 6)
- Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale(Weeks 1, 2, 3, 4, 5, and 6)
- Vital signs(Weeks 1, 2, 3, 4, 5, and 6)
- Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score(Week 6)
- Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)(Baseline and Week 6)
- Weekly change in the PDSS-A total score(Weeks 1, 2, 3, 4, 5, and 6)
- Weekly change and endpoint change from baseline in CGI-lmprovement scale(Weeks 1, 2, 3, 4, 5, and 6)
Investigators
Study Sites (1)
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