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

NCT00634790 | Terminated Phase 4 DMC

• 1 other identifier: A6131004
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 47

Brief Summary

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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

alprazolam group

ACTIVE COMPARATOR

Drug: alprazolam XR

Interventions

alprazolam XR DRUG

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.

Also known as: Xanax XR

alprazolam group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (47)

Pfizer Investigational Site

Little Rock, Alaska, 72223, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85016, United States

Location

Pfizer Investigational Site

Scottsdale, Arizona, 85251, United States

Location

Pfizer Investigational Site

Burbank, California, 91506, United States

Location

Pfizer Investigational Site

El Centro, California, 92243, United States

Location

Pfizer Investigational Site

La Mesa, California, 91942, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90010, United States

Location

Pfizer Investigational Site

Oceanside, California, 92056, United States

Location

Pfizer Investigational Site

San Diego, California, 92111, United States

Location

Pfizer Investigational Site

San Marcos, California, 92078, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32610, United States

Location

Pfizer Investigational Site

Hialeah, Florida, 33013, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

Location

Pfizer Investigational Site

North Miami, Florida, 33161, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33710, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33409, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30030, United States

Location

Pfizer Investigational Site

Boise, Idaho, 83702, United States

Location

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Schaumburg, Illinois, 60194, United States

Location

Pfizer Investigational Site

Terre Haute, Indiana, 47802, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66214, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40509, United States

Location

Pfizer Investigational Site

Owensboro, Kentucky, 42301, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70112, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70114, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21208, United States

Location

Pfizer Investigational Site

Clinton Township, Michigan, 48038, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55101, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68131, United States

Location

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Las Vegas, Nevada, 89102, United States

Location

Pfizer Investigational Site

Clementon, New Jersey, 08021, United States

Location

Pfizer Investigational Site

Kenilworth, New Jersey, 07033, United States

Location

Pfizer Investigational Site

Morristown, New Jersey, 07962, United States

Location

Pfizer Investigational Site

Bismarck, North Dakota, 59501, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106-5080, United States

Location

Pfizer Investigational Site

Lyndhurst, Ohio, 44124, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Pfizer Investigational Site

Hershey, Pennsylvania, 17033-0850, United States

Location

Pfizer Investigational Site

Media, Pennsylvania, 19063, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29201, United States

Location

Pfizer Investigational Site

Selmer, Tennessee, 38375-1645, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84117, United States

Location

Pfizer Investigational Site

Midlothian, Virginia, 23112, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23294, United States

Location

Pfizer Investigational Site

Middleton, Wisconsin, 53562, United States

Location

Related Links

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

MeSH Terms

Conditions

Panic Disorder

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: May 1, 2004
• Study Completion: October 1, 2004
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (47)