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

Condition(s) targeted: Panic Disorder

Intervention: alprazolam XR (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall

Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam

The incidence of treatment-emergent adverse event during treatment with alprazolam XR

Secondary outcome:

Descriptive estimates of the persistence of safety events and adverse events at study endpoint

Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores

Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score

Endpoint change from baseline to Week 24 in CGI-Severity score

Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score

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.

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Little Rock, Alaska 72223, United States

Pfizer Investigational Site, Scottsdale, Arizona 85251, United States

Pfizer Investigational Site, Phoenix, Arizona 85016, United States

Pfizer Investigational Site, Elcentro, California 92243, United States

Pfizer Investigational Site, La Mesa, California 91942, United States

Pfizer Investigational Site, Oceanside, California 92056, United States

Pfizer Investigational Site, San Marcos, California 92078, United States

Pfizer Investigational Site, Los Angeles, California 90010, United States

Pfizer Investigational Site, San Diego, California 92111, United States

Pfizer Investigational Site, Burbank, California 91506, United States

Pfizer Investigational Site, Hialeah, Florida 33013, United States

Pfizer Investigational Site, North Miami, Florida 33161, United States

Pfizer Investigational Site, St. Petersburg, Florida 33710, United States

Pfizer Investigational Site, Gainesville, Florida 32610, United States

Pfizer Investigational Site, WEST PALM BEACH, Florida 33409, United States

Pfizer Investigational Site, Jacksonville, Florida 32216, United States

Pfizer Investigational Site, Decatur, Georgia 30030, United States

Pfizer Investigational Site, Boise, Idaho 83702, United States

Pfizer Investigational Site, Schaumburg, Illinois 60194, United States

Pfizer Investigational Site, Terre Haute, Indiana 47802, United States

Pfizer Investigational Site, Overland Park, Kansas 66214, United States

Pfizer Investigational Site, Owensboro, Kentucky 42301, United States

Pfizer Investigational Site, Lexington, Kentucky 40509, United States

Pfizer Investigational Site, New Orleans, Louisiana 70114, United States

Pfizer Investigational Site, New Orleans, Louisiana 70112, United States

Pfizer Investigational Site, Baltimore, Maryland 21208, United States

Pfizer Investigational Site, Clinton Township, Michigan 48038, United States

Pfizer Investigational Site, Saint Paul, Minnesota 55101, United States

Pfizer Investigational Site, Omaha, Nebraska 68131, United States

Pfizer Investigational Site, Las Vegas, Nevada 89102, United States

Pfizer Investigational Site, Kenilworth, New Jersey 07033, United States

Pfizer Investigational Site, Morristown, New Jersey 07962, United States

Pfizer Investigational Site, Clementon, New Jersey 08021, United States

Pfizer Investigational Site, Bismarck, North Dakota 59501, United States

Pfizer Investigational Site, Cleveland, Ohio 44106-5080, United States

Pfizer Investigational Site, Lyndhurst, Ohio 44124, United States

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, Media, Pennsylvania 19063, United States

Pfizer Investigational Site, Hershey, Pennsylvania 17033-0850, United States

Pfizer Investigational Site, Bala Cynwyd, Pennsylvania 19004, United States

Pfizer Investigational Site, Columbia, South Carolina 29201, United States

Pfizer Investigational Site, Selmer, Tennessee 38375-1645, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Salt Lake City, Utah 84117, United States

Pfizer Investigational Site, Midlothian, Virginia 23112, United States

Pfizer Investigational Site, Richmond, Virginia 23294, United States

Pfizer Investigational Site, Middleton, Wisconsin 53562, United States

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

Link to ClinicalStudyResults.org Posting

Starting date: May 2004
Ending date: October 2004
Last updated: April 7, 2008