Clinical trial NCT00635076: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Panic Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 3
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
timeFrame: Week 24 (taper baseline), Weeks 25-29, and end of taper visit
measure: The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR
timeFrame: Weeks 6, 8, 12, 16, 20, and 24
measure: Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
timeFrame: Week 24
Secondary outcomes:
measure: Endpoint change from baseline in Hamilton Anxiety Rating scale
timeFrame: Weeks 12 and 24
measure: Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores
timeFrame: Weeks 12 an 24
measure: Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale
timeFrame: Weeks 12 and 24
measure: Endpoint change compared with baseline in CGI-Severity score
timeFrame: Weeks 12 and 24
measure: Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
timeFrame: Weeks 12 and 24
measure: Descriptive estimates of the persistence of safety events and adverse events
timeFrame: Week 24
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Middleton
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: