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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo group
• Active Comparator: Alprazolam XR group

Primary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
  • Time Frame: Week 24
    Safety Issue?: No

Secondary Measures

• Endpoint change from baseline in Hamilton Anxiety Rating scale
  • Time Frame: Weeks 12 and 24
    Safety Issue?: No
• Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores
  • Time Frame: Weeks 12 an 24
    Safety Issue?: No
• Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale
  • Time Frame: Weeks 12 and 24
    Safety Issue?: No
• Endpoint change compared with baseline in CGI-Severity score
  • Time Frame: Weeks 12 and 24
    Safety Issue?: No
• Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
  • Time Frame: Weeks 12 and 24
    Safety Issue?: No
• Descriptive estimates of the persistence of safety events and adverse events
  • Time Frame: Week 24
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00635076

Study ID Number: A6131007

ClinicalTrials.gov Identifier: NCT00635076

Health Authority: United States: Food and Drug Administration

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