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

NCT00635531 | Terminated Phase 4 DMC

• 1 other identifier: A6131002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 18

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

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (2)

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

  Week 6

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

  Week 6

Secondary Outcomes (11)

• Weekly change in the PDSS-A total score

  Weeks 1, 2, 3, 4, 5, and 6

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

  Weeks 1, 2, 3, 4, 5, and 6

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

  Weeks 1, 2, 3, 4, 5, and 6

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

  Weeks 1, 2, 3, 4, 5, and 6

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

  Week 6

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Other: placebo

Alprazolam XR group

ACTIVE COMPARATOR

Drug: alprazolam XR

Interventions

placebo OTHER

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

Placebo group

alprazolam XR DRUG

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.

Also known as: Xanax XR

Alprazolam XR group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (18)

Pfizer Investigational Site

Hialeah, Florida, 33013, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

Location

Pfizer Investigational Site

North Miami, Florida, 33161, United States

Location

Pfizer Investigational Site

Boise, Idaho, 83702, United States

Location

Pfizer Investigational Site

Terre Haute, Indiana, 47802, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21208, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55101, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68131, United States

Location

Pfizer Investigational Site

Lyndhurst, Ohio, 44124, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

Media, Pennsylvania, 19063, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29201, United States

Location

Pfizer Investigational Site

Lake Jackson, Texas, 77566, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Wichita Falls, Texas, 76309, United States

Location

Pfizer Investigational Site

Bellevue, Washington, 98004, United States

Location

Pfizer Investigational Site

Middleton, Wisconsin, 53562, United States

Location

Related Links

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

MeSH Terms

Conditions

Panic Disorder

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: April 1, 2004
• Study Completion: September 1, 2004
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (18)