A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks

An Open-label Study to Assess the Safety and Tolerability of Xanax XR in the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks

The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.

Study Overview

• Status: Terminated
• Conditions: Panic Disorder
• Intervention / Treatment: 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): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Little Rock, Alaska, United States, 72223
      • Pfizer Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Pfizer Investigational Site
    • Scottsdale, Arizona, United States, 85251
      • Pfizer Investigational Site
  • California
    • Burbank, California, United States, 91506
      • Pfizer Investigational Site
    • El Centro, California, United States, 92243
      • Pfizer Investigational Site
    • La Mesa, California, United States, 91942
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90010
      • Pfizer Investigational Site
    • Oceanside, California, United States, 92056
      • Pfizer Investigational Site
    • San Diego, California, United States, 92111
      • Pfizer Investigational Site
    • San Marcos, California, United States, 92078
      • Pfizer Investigational Site
  • Florida
    • Gainesville, Florida, United States, 32610
      • Pfizer Investigational Site
    • 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
    • Saint Petersburg, Florida, United States, 33710
      • Pfizer Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • Pfizer Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Pfizer Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83702
      • Pfizer Investigational Site
  • Illinois
    • Schaumburg, Illinois, United States, 60194
      • Pfizer Investigational Site
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66214
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Pfizer Investigational Site
    • Owensboro, Kentucky, United States, 42301
      • Pfizer Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Pfizer Investigational Site
    • New Orleans, Louisiana, United States, 70112
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pfizer Investigational Site
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Pfizer Investigational Site
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Pfizer Investigational Site
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • Pfizer Investigational Site
    • Kenilworth, New Jersey, United States, 07033
      • Pfizer Investigational Site
    • Morristown, New Jersey, United States, 07962
      • Pfizer Investigational Site
  • North Dakota
    • Bismarck, North Dakota, United States, 59501
      • Pfizer Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44106-5080
      • Pfizer Investigational Site
    • Lyndhurst, Ohio, United States, 44124
      • Pfizer Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pfizer Investigational Site
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Pfizer Investigational Site
    • Hershey, Pennsylvania, United States, 17033-0850
      • Pfizer Investigational Site
    • Media, Pennsylvania, United States, 19063
      • Pfizer Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Pfizer Investigational Site
  • Tennessee
    • Selmer, Tennessee, United States, 38375-1645
      • Pfizer Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Pfizer Investigational Site
  • Virginia
    • Midlothian, Virginia, United States, 23112
      • Pfizer Investigational Site
    • Richmond, Virginia, United States, 23294
      • 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:

• Subjects must meet one of the following 6 diagnoses: a. A current diagnosis of panic disorder with or without agoraphobia; b. Generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. Social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. Separation anxiety with a history of at least one panic attack in the course of their illness; e. Posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. Anxiety not otherwise specified with a history of at least one panic attack in the course of their illness.
• Educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with.

Exclusion Criteria:

• Current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence.
• Current (in the past 3 months) diagnosis of alcohol and/or substance abuse.
• Primary diagnosis of 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 eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder.
• A Childhood Depression Rating Scale, Revised score >35.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: alprazolam group

Drug: alprazolam XR; Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days.; Other Names: Xanax XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall	24 weeks
Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam	6 week taper
The incidence of treatment-emergent adverse event during treatment with alprazolam XR	24 weeks with taper

Secondary Outcome Measures

Outcome Measure	Time Frame
Descriptive estimates of the persistence of safety events and adverse events at study endpoint	24 weeks with taper
Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores	24 weeks
Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score	24 weeks
Endpoint change from baseline to Week 24 in CGI-Severity score	24 weeks
Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score	24 weeks

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: May 1, 2004
• Study Completion (Actual): October 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: A6131004