A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

A Randomized, Double-blind, Placebo-controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder

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

Study Overview

• Status: Terminated
• Conditions: Panic Disorder
• Intervention / Treatment: Other: placebo; Drug: alprazolam XR

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33013
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Pfizer Investigational Site
    • North Miami, Florida, United States, 33161
      • Pfizer Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83702
      • Pfizer Investigational Site
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Pfizer Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pfizer Investigational Site
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Pfizer Investigational Site
  • Ohio
    • Lyndhurst, Ohio, United States, 44124
      • Pfizer Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pfizer Investigational Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Pfizer Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Pfizer Investigational Site
  • Texas
    • Lake Jackson, Texas, United States, 77566
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
    • Wichita Falls, Texas, United States, 76309
      • Pfizer Investigational Site
  • Washington
    • Bellevue, Washington, United States, 98004
      • Pfizer Investigational Site
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Other: placebo; Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
Active Comparator: Alprazolam XR group	Drug: alprazolam XR; 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.; Other Names: Xanax XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score	Week 6
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks	Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Weekly change in the PDSS-A total score	Weeks 1, 2, 3, 4, 5, and 6
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale	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
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 the Hamilton anxiety rating scale total score	Week 6
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score	Week 6
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire	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
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)	Baseline and Week 6
Population pharmacokinetic analysis	Weeks 2, 4, and 6
Vital signs	Weeks 1, 2, 3, 4, 5, and 6

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: March 5, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (Estimate): March 13, 2008

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Alprazolam
• Other Study ID Numbers: A6131002