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NCT00634790 Clinical Trial

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

Panic Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00634790
Other study ID # A6131004
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 2004
Est. completion date October 2004

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 49
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Pfizer Investigational Site Bala-Cynwyd Pennsylvania
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Bismarck North Dakota
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Burbank California
United States Pfizer Investigational Site Clementon New Jersey
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Clinton Township Michigan
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site El Centro California
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Hershey Pennsylvania
United States Pfizer Investigational Site Hialeah Florida
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Kenilworth New Jersey
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Little Rock Alaska
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Lyndhurst Ohio
United States Pfizer Investigational Site Media Pennsylvania
United States Pfizer Investigational Site Middleton Wisconsin
United States Pfizer Investigational Site Midlothian Virginia
United States Pfizer Investigational Site Morristown New Jersey
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site North Miami Florida
United States Pfizer Investigational Site Oceanside California
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Owensboro Kentucky
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Saint Paul Minnesota
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Marcos California
United States Pfizer Investigational Site Schaumburg Illinois
United States Pfizer Investigational Site Scottsdale Arizona
United States Pfizer Investigational Site Selmer Tennessee
United States Pfizer Investigational Site Terre Haute Indiana
United States Pfizer Investigational Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall 24 weeks
Primary Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam 6 week taper
Primary The incidence of treatment-emergent adverse event during treatment with alprazolam XR 24 weeks with taper
Secondary Descriptive estimates of the persistence of safety events and adverse events at study endpoint 24 weeks with taper
Secondary Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores 24 weeks
Secondary Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score 24 weeks
Secondary Endpoint change from baseline to Week 24 in CGI-Severity score 24 weeks
Secondary Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score 24 weeks
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