Clinical trial NCT00635531: A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder
Official title: A Randomized, Double-blind, Placebo-controlled Study of 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: 16
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 efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (XR) for the treatment of 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 DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents
* At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening
* At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline
* At least one 4-symptom panic attack in the 7 days prior to baseline

Exclusion Criteria:

* Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence
* Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder
* Any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder
* A CDRS-R score \>35

Primary outcomes:
measure: Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score
timeFrame: Week 6
measure: Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks
timeFrame: Week 6
Secondary outcomes:
measure: Weekly change in the PDSS-A total score
timeFrame: Weeks 1, 2, 3, 4, 5, and 6
measure: Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale
timeFrame: Weeks 1, 2, 3, 4, 5, and 6
measure: Weekly change and endpoint change from baseline in CGI-lmprovement scale
timeFrame: Weeks 1, 2, 3, 4, 5, and 6
measure: Weekly change and and endpoint change from baseline in PDSS-A item scores
timeFrame: Weeks 1, 2, 3, 4, 5, and 6
measure: Endpoint change from baseline in the Hamilton anxiety rating scale total score
timeFrame: Week 6
measure: Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score
timeFrame: Week 6
measure: Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire
timeFrame: Week 6
measure: Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit
timeFrame: Baseline and Week 6
measure: Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)
timeFrame: Baseline and Week 6
measure: Population pharmacokinetic analysis
timeFrame: Weeks 2, 4, and 6
measure: Vital signs
timeFrame: Weeks 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: North Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Saint Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lyndhurst
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Media
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Pfizer Investigational Site
state: Washington
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: