Clinical trial NCT00634790: A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
Official title: An Open-label Study to Assess the Safety and Tolerability of Xanax XR in the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Panic Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 49
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.

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:

* Subjects must meet one of the following 6 diagnoses: a. A current diagnosis of panic disorder with or without agoraphobia; b. Generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. Social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. Separation anxiety with a history of at least one panic attack in the course of their illness; e. Posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. Anxiety not otherwise specified with a history of at least one panic attack in the course of their illness.
* Educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with.

Exclusion Criteria:

* Current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence.
* Current (in the past 3 months) diagnosis of alcohol and/or substance abuse.
* Primary diagnosis of 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 eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder.
* A Childhood Depression Rating Scale, Revised score \>35.

Primary outcomes:
measure: Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall
timeFrame: 24 weeks
measure: Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam
timeFrame: 6 week taper
measure: The incidence of treatment-emergent adverse event during treatment with alprazolam XR
timeFrame: 24 weeks with taper
Secondary outcomes:
measure: Descriptive estimates of the persistence of safety events and adverse events at study endpoint
timeFrame: 24 weeks with taper
measure: Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores
timeFrame: 24 weeks
measure: Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score
timeFrame: 24 weeks
measure: Endpoint change from baseline to Week 24 in CGI-Severity score
timeFrame: 24 weeks
measure: Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Burbank
country: United States
facility: Pfizer Investigational Site
state: California
city: El Centro
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Marcos
country: United States
facility: Pfizer Investigational Site
state: California
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
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: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Schaumburg
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Owensboro
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Clinton Township
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Saint Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Clementon
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Kenilworth
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Morristown
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lyndhurst
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Media
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Selmer
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Midlothian
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
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: