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 enrollmentJuly 2004

ConditionsPanic Disorder

Interventionsplacebo alprazolam XR

Drugsalprazolam XR

Overview

Phase: Phase 4
Intervention: placebo
Conditions: Panic Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 3
Locations: 1
Primary Endpoint: Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

September 2004

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Intervention: placebo

Alprazolam XR group

Intervention: alprazolam XR

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)