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

Purpose

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

Condition	Intervention	Phase
Panic Disorder	Other: placebo Drug: alprazolam XR	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Alprazolam

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weekly change in the PDSS-A total score [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
Weekly change and endpoint change from baseline in CGI-lmprovement scale [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
Weekly change and and endpoint change from baseline in PDSS-A item scores [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
Endpoint change from baseline in the Hamilton anxiety rating scale total score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
Population pharmacokinetic analysis [ Time Frame: Weeks 2, 4, and 6 ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Weeks 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	April 2004
Study Completion Date:	September 2004

Arms	Assigned Interventions
Placebo Comparator: Placebo group	Other: placebo Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
Active Comparator: Alprazolam XR group	Drug: alprazolam XR Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period. Other Name: Xanax XR

Arms

Assigned Interventions

Placebo Comparator: Placebo group

Other: placebo

Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam

Active Comparator: Alprazolam XR group

Drug: alprazolam XR

Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period.

Other Name: Xanax XR

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

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635531

Locations

United States, Florida
Pfizer Investigational Site
Hialeah, Florida, United States, 33013
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
North Miami, Florida, United States, 33161
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83702
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21208
United States, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55101
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Ohio
Pfizer Investigational Site
Lyndhurst, Ohio, United States, 44124
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Pfizer Investigational Site
Media, Pennsylvania, United States, 19063
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Washington
Pfizer Investigational Site
Bellevue, Washington, United States, 98004
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00635531 History of Changes
Other Study ID Numbers:	A6131002
Study First Received:	March 5, 2008
Last Updated:	April 7, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Panic Disorder
Anxiety Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013