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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall
Time Frame: 24 weeks
24 weeks
Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam
Time Frame: 6 week taper
6 week taper
The incidence of treatment-emergent adverse event during treatment with alprazolam XR
Time Frame: 24 weeks with taper
24 weeks with taper

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Descriptive estimates of the persistence of safety events and adverse events at study endpoint
Time Frame: 24 weeks with taper
24 weeks with taper
Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores
Time Frame: 24 weeks
24 weeks
Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score
Time Frame: 24 weeks
24 weeks
Endpoint change from baseline to Week 24 in CGI-Severity score
Time Frame: 24 weeks
24 weeks
Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6131004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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