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A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
This study has been terminated.
( Please see Detailed Description for termination reason. )
First Received: March 5, 2008   Last Updated: April 7, 2008   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00634790
  Purpose

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.


Condition Intervention Phase
Panic Disorder
Drug: alprazolam XR
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam [ Time Frame: 6 week taper ] [ Designated as safety issue: Yes ]
  • The incidence of treatment-emergent adverse event during treatment with alprazolam XR [ Time Frame: 24 weeks with taper ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Descriptive estimates of the persistence of safety events and adverse events at study endpoint [ Time Frame: 24 weeks with taper ] [ Designated as safety issue: Yes ]
  • Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Endpoint change from baseline to Week 24 in CGI-Severity score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2004
Study Completion Date: October 2004
Arms Assigned Interventions
alprazolam group: Active Comparator 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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634790

  Hide Study Locations
Locations
United States, Alaska
Pfizer Investigational Site
Little Rock, Alaska, United States, 72223
United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85251
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
United States, California
Pfizer Investigational Site
Elcentro, California, United States, 92243
Pfizer Investigational Site
La Mesa, California, United States, 91942
Pfizer Investigational Site
Oceanside, California, United States, 92056
Pfizer Investigational Site
San Marcos, California, United States, 92078
Pfizer Investigational Site
Los Angeles, California, United States, 90010
Pfizer Investigational Site
San Diego, California, United States, 92111
Pfizer Investigational Site
Burbank, California, United States, 91506
United States, Florida
Pfizer Investigational Site
Hialeah, Florida, United States, 33013
Pfizer Investigational Site
North Miami, Florida, United States, 33161
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33710
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
Pfizer Investigational Site
WEST PALM BEACH, Florida, United States, 33409
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
United States, Georgia
Pfizer Investigational Site
Decatur, Georgia, United States, 30030
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83702
United States, Illinois
Pfizer Investigational Site
Schaumburg, Illinois, United States, 60194
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66214
United States, Kentucky
Pfizer Investigational Site
Owensboro, Kentucky, United States, 42301
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70114
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21208
United States, Michigan
Pfizer Investigational Site
Clinton Township, Michigan, United States, 48038
United States, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55101
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Pfizer Investigational Site
Kenilworth, New Jersey, United States, 07033
Pfizer Investigational Site
Morristown, New Jersey, United States, 07962
Pfizer Investigational Site
Clementon, New Jersey, United States, 08021
United States, North Dakota
Pfizer Investigational Site
Bismarck, North Dakota, United States, 59501
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106-5080
Pfizer Investigational Site
Lyndhurst, Ohio, United States, 44124
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Pfizer Investigational Site
Media, Pennsylvania, United States, 19063
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033-0850
Pfizer Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
Pfizer Investigational Site
Selmer, Tennessee, United States, 38375-1645
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84117
United States, Virginia
Pfizer Investigational Site
Midlothian, Virginia, United States, 23112
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A6131004
Study First Received: March 5, 2008
Last Updated: April 7, 2008
ClinicalTrials.gov Identifier: NCT00634790     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Pharmacologic Actions
Panic Disorder
Pathologic Processes
Alprazolam
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009