A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

Condition(s) targeted: Panic Disorder

Intervention: placebo (Other); alprazolam XR (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

Primary outcome:

Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score

Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks

Secondary outcome:

Weekly change in the PDSS-A total score

Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale

Weekly change and endpoint change from baseline in CGI-lmprovement scale

Weekly change and and endpoint change from baseline in PDSS-A item scores

Endpoint change from baseline in the Hamilton anxiety rating scale total score

Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score

Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire

Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit

Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)

Population pharmacokinetic analysis

Vital signs

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.

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

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

Pfizer Investigational Site, Hialeah, Florida 33013, United States

Pfizer Investigational Site, North Miami, Florida 33161, United States

Pfizer Investigational Site, Jacksonville, Florida 32216, United States

Pfizer Investigational Site, Boise, Idaho 83702, United States

Pfizer Investigational Site, Terre Haute, Indiana 47802, United States

Pfizer Investigational Site, New Orleans, Louisiana, United States

Pfizer Investigational Site, Baltimore, Maryland 21208, United States

Pfizer Investigational Site, Saint Paul, Minnesota 55101, United States

Pfizer Investigational Site, Omaha, Nebraska 68131, United States

Pfizer Investigational Site, Lyndhurst, Ohio 44124, United States

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, Media, Pennsylvania 19063, United States

Pfizer Investigational Site, Columbia, South Carolina 29201, United States

Pfizer Investigational Site, Lake Jackson, Texas 77566, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Wichita Falls, Texas 76309, United States

Pfizer Investigational Site, Bellevue, Washington 98004, United States

Pfizer Investigational Site, Middleton, Wisconsin 53562, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: April 2004
Ending date: September 2004
Last updated: April 7, 2008