Back to resultsA Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder
Primary Purpose
Panic Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
placebo
alprazolam XR
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo group
Alprazolam XR group
Arm Description
Outcomes
Primary Outcome Measures
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Secondary Outcome Measures
Weekly change in the PDSS-A total score
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale
Weekly change and endpoint change from baseline in CGI-lmprovement scale
Weekly change and and endpoint change from baseline in PDSS-A item scores
Endpoint change from baseline in the Hamilton anxiety rating scale total score
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire
Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)
Population pharmacokinetic analysis
Vital signs
Full Information
NCT ID
NCT00635531
First Posted
March 5, 2008
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00635531
Brief Title
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Please see Detailed Description for termination reason.
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
Alprazolam XR group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
Intervention Type
Drug
Intervention Name(s)
alprazolam XR
Other Intervention Name(s)
Xanax XR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score
Time Frame
Week 6
Title
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Weekly change in the PDSS-A total score
Time Frame
Weeks 1, 2, 3, 4, 5, and 6
Title
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale
Time Frame
Weeks 1, 2, 3, 4, 5, and 6
Title
Weekly change and endpoint change from baseline in CGI-lmprovement scale
Time Frame
Weeks 1, 2, 3, 4, 5, and 6
Title
Weekly change and and endpoint change from baseline in PDSS-A item scores
Time Frame
Weeks 1, 2, 3, 4, 5, and 6
Title
Endpoint change from baseline in the Hamilton anxiety rating scale total score
Time Frame
Week 6
Title
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score
Time Frame
Week 6
Title
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire
Time Frame
Week 6
Title
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
Title
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)
Time Frame
Baseline and Week 6
Title
Population pharmacokinetic analysis
Time Frame
Weeks 2, 4, and 6
Title
Vital signs
Time Frame
Weeks 1, 2, 3, 4, 5, and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Pfizer Investigational Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Pfizer Investigational Site
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Pfizer Investigational Site
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pfizer Investigational Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Pfizer Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Pfizer Investigational Site
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6131002&StudyName=A%20Study%20to%20Evaluate%20the%20Use%20of%20Extended%20Release%20Alprazolam%20in%20the%20Treatment%20of%20Adolescents%20with%20Panic%20Disorder%20
Description
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Learn more about this trial
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder
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