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

Condition(s) targeted: Panic Disorder

Intervention: placebo (Other); alprazolam XR (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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

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

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

Secondary outcome:

Endpoint change from baseline in Hamilton Anxiety Rating scale

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

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

Endpoint change compared with baseline in CGI-Severity score

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

Descriptive estimates of the persistence of safety events and adverse events

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.

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Middleton, Wisconsin 53562, United States

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

Link to ClinicalStudyResults.org Posting

Starting date: July 2004
Ending date: September 2004
Last updated: April 7, 2008