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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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ClinicalTrials.gov Identifier: NCT00635076
Recruitment Status : Terminated (Please see Detailed Description for the termination reason.)
First Posted : March 13, 2008
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 5, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date April 10, 2008
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
  • 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 ]
  • 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 ]
  • Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00635076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
  • Endpoint change from baseline in Hamilton Anxiety Rating scale [ Time Frame: Weeks 12 and 24 ]
  • Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores [ Time Frame: Weeks 12 an 24 ]
  • Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale [ Time Frame: Weeks 12 and 24 ]
  • Endpoint change compared with baseline in CGI-Severity score [ Time Frame: Weeks 12 and 24 ]
  • Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score [ Time Frame: Weeks 12 and 24 ]
  • Descriptive estimates of the persistence of safety events and adverse events [ Time Frame: Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Long-Term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE
  • Other: placebo
    Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
  • Drug: alprazolam XR
    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.
    Other Name: Xanax XR
Study Arms  ICMJE
  • Placebo Comparator: Placebo group
    Intervention: Other: placebo
  • Active Comparator: Alprazolam XR group
    Intervention: Drug: alprazolam XR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 5, 2008)
3
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635076
Other Study ID Numbers  ICMJE A6131007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP