Back to resultsA Study to Assess the Long-term Use of Alprazolam Extended Release (XL) 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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of panic disorder with or without agoraphobia based on the Mini-International Neuropsychiatric Interview for Children and Adolescents
- Subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline
- To enter Study A6131007, subjects must have completed Study A6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment.
Exclusion Criteria:
- Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.
Sites / Locations
- 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
Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR
Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
Secondary Outcome Measures
Endpoint change from baseline in Hamilton Anxiety Rating scale
Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores
Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale
Endpoint change compared with baseline in CGI-Severity score
Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Descriptive estimates of the persistence of safety events and adverse events
Full Information
NCT ID
NCT00635076
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
NCT00635076
Brief Title
A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder
Official Title
A Randomized, Double-blind, Placebo-controlled Study of Continuation Treatment With 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 the termination reason.
Study Start Date
July 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 long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in 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
3 (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
Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
Intervention Type
Drug
Intervention Name(s)
alprazolam XR
Other Intervention Name(s)
Xanax XR
Intervention Description
Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced.
Primary Outcome Measure Information:
Title
Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
Time Frame
Week 24 (taper baseline), Weeks 25-29, and end of taper visit
Title
The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR
Time Frame
Weeks 6, 8, 12, 16, 20, and 24
Title
Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Endpoint change from baseline in Hamilton Anxiety Rating scale
Time Frame
Weeks 12 and 24
Title
Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores
Time Frame
Weeks 12 an 24
Title
Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale
Time Frame
Weeks 12 and 24
Title
Endpoint change compared with baseline in CGI-Severity score
Time Frame
Weeks 12 and 24
Title
Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
Time Frame
Weeks 12 and 24
Title
Descriptive estimates of the persistence of safety events and adverse events
Time Frame
Week 24
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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of panic disorder with or without agoraphobia based on the Mini-International Neuropsychiatric Interview for Children and Adolescents
Subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline
To enter Study A6131007, subjects must have completed Study A6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment.
Exclusion Criteria:
Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.
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
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
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
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=A6131007&StudyName=A%20study%20to%20assess%20the%20long-term%20use%20of%20alprazolam%20extended%20release%20%28XL%29%20in%20the%20treatment%20of%20adolescents%20with%20panic%20disorder
Description
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Learn more about this trial
A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder
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