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

NCT00635076 | Terminated Phase 4 DMC

• 1 other identifier: A6131007
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (3)

• Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam

  Week 24 (taper baseline), Weeks 25-29, and end of taper visit

• The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR

  Weeks 6, 8, 12, 16, 20, and 24

• Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall

  Week 24

Secondary Outcomes (6)

• Endpoint change from baseline in Hamilton Anxiety Rating scale

  Weeks 12 and 24

• Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores

  Weeks 12 an 24

• Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale

  Weeks 12 and 24

• Endpoint change compared with baseline in CGI-Severity score

  Weeks 12 and 24

• Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score

  Weeks 12 and 24

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Other: placebo

Alprazolam XR group

ACTIVE COMPARATOR

Drug: alprazolam XR

Interventions

placebo OTHER

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

Placebo group

alprazolam XR DRUG

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.

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 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.

Sponsors & Collaborators

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

Study Sites (3)

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, 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: July 1, 2004
• Study Completion: September 1, 2004
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (3)