A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00635076
• Other study ID #: A6131007
• Status: Terminated
• Phase: Phase 4
• Start date: July 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 long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in 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: 3
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• A primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of panic disorder with or without agoraphobia based on the Mini-International Neuropsychiatric Interview for Children and Adolescents

• Subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline

• To enter Study A6131007, subjects must have completed Study A6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment.

Exclusion Criteria:

• Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Other:
• placebo
Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).

Drug:
• alprazolam XR
Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Middleton	Wisconsin
United States	Pfizer Investigational Site	San Antonio	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	Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam		Week 24 (taper baseline), Weeks 25-29, and end of taper visit
Primary	The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR		Weeks 6, 8, 12, 16, 20, and 24
Primary	Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall		Week 24
Secondary	Endpoint change from baseline in Hamilton Anxiety Rating scale		Weeks 12 and 24
Secondary	Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores		Weeks 12 an 24
Secondary	Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale		Weeks 12 and 24
Secondary	Endpoint change compared with baseline in CGI-Severity score		Weeks 12 and 24
Secondary	Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score		Weeks 12 and 24
Secondary	Descriptive estimates of the persistence of safety events and adverse events		Week 24

External Links

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