A Study to Assess the Long-Term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

• ClinicalTrials.gov Identifier: NCT00635076
• Recruitment Status: Terminated
• First Posted: March 13, 2008
• Last Update Posted: April 10, 2008
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: March 5, 2008
• First Posted Date: March 13, 2008
• Last Update Posted Date: April 10, 2008
• Study Start Date: July 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT00635076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Panic Disorder

Intervention

• 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

• Placebo Comparator: Placebo group
  Intervention: Other: placebo
• Active Comparator: Alprazolam XR group
  Intervention: Drug: alprazolam XR

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 5, 2008): 3
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2004
• Primary Completion Date: Not Provided

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00635076
• Other Study ID Numbers: A6131007
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2008