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

Panic Disorder Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00635531
• Other study ID #: A6131002
• Status: Terminated
• Phase: Phase 4
• Start date: April 2004
• Est. completion date: September 2004

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Panic Disorder

Intervention

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

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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bellevue	Washington
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Hialeah	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Lyndhurst	Ohio
United States	Pfizer Investigational Site	Media	Pennsylvania
United States	Pfizer Investigational Site	Middleton	Wisconsin
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	North Miami	Florida
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Saint Paul	Minnesota
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Terre Haute	Indiana
United States	Pfizer Investigational Site	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endpoint change from baseline in the Panic Disorder Severity Scale for Adolescents (PDSS-A) total score		Week 6
Primary	Endpoint change from baseline in the weekly frequency of 4-symptom panic attacks		Week 6
Secondary	Weekly change in the PDSS-A total score		Weeks 1, 2, 3, 4, 5, and 6
Secondary	Weekly change and endpoint change from baseline in Clinical Global Impression (CGI)-Severity scale		Weeks 1, 2, 3, 4, 5, and 6
Secondary	Weekly change and endpoint change from baseline in CGI-lmprovement scale		Weeks 1, 2, 3, 4, 5, and 6
Secondary	Weekly change and and endpoint change from baseline in PDSS-A item scores		Weeks 1, 2, 3, 4, 5, and 6
Secondary	Endpoint change from baseline in the Hamilton anxiety rating scale total score		Week 6
Secondary	Endpoint change from baseline in the Children's Depression Rating Scale (CDRS-R) total score		Week 6
Secondary	Endpoint change from baseline in Pediatric Quality of Life, Enjoyment, Satisfaction Questionnaire		Week 6
Secondary	Safety assessments will include physical examination, electrocardiogram and laboratory assessments obtained at initial screening, and at the end-of-study visit		Baseline and Week 6
Secondary	Cognitive and memory effects (free verbal recall test and Digit- Symbol Coding Test)		Baseline and Week 6
Secondary	Population pharmacokinetic analysis		Weeks 2, 4, and 6
Secondary	Vital signs		Weeks 1, 2, 3, 4, 5, and 6

External Links

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