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A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00635531
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : March 13, 2008
Last Update Posted : April 10, 2008
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Brief Summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with panic disorder

Condition or disease Intervention/treatment Phase
Panic Disorder Other: placebo Drug: alprazolam XR Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder
Study Start Date : April 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder
Drug Information available for: Alprazolam

Arm Intervention/treatment
Placebo Comparator: Placebo group Other: placebo
Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam

Active Comparator: Alprazolam XR group Drug: alprazolam XR
Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period.
Other Name: Xanax XR

Primary Outcome Measures :
  1. Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score [ Time Frame: Week 6 ]
  2. Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Weekly change in the PDSS-A total score [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ]
  2. Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ]
  3. Weekly change and endpoint change from baseline in CGI-lmprovement scale [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ]
  4. Weekly change and and endpoint change from baseline in PDSS-A item scores [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ]
  5. Endpoint change from baseline in the Hamilton anxiety rating scale total score [ Time Frame: Week 6 ]
  6. Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score [ Time Frame: Week 6 ]
  7. Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire [ Time Frame: Week 6 ]
  8. Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit [ Time Frame: Baseline and Week 6 ]
  9. Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test) [ Time Frame: Baseline and Week 6 ]
  10. Population pharmacokinetic analysis [ Time Frame: Weeks 2, 4, and 6 ]
  11. Vital signs [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A primary DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents
  • At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening
  • At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline
  • At least one 4-symptom panic attack in the 7 days prior to baseline

Exclusion Criteria:

  • Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence
  • Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, 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 Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder
  • A CDRS-R score >35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00635531

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United States, Florida
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
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83702
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21208
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, Ohio
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
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Washington
Pfizer Investigational Site
Bellevue, Washington, United States, 98004
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00635531     History of Changes
Other Study ID Numbers: A6131002
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008

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