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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00635076

Purpose

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.

Condition	Intervention	Phase
Panic Disorder	Other: placebo Drug: alprazolam XR	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Alprazolam

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam [ Time Frame: Week 24 (taper baseline), Weeks 25-29, and end of taper visit ] [ Designated as safety issue: No ]
The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR [ Time Frame: Weeks 6, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endpoint change from baseline in Hamilton Anxiety Rating scale [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores [ Time Frame: Weeks 12 an 24 ] [ Designated as safety issue: No ]
Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Endpoint change compared with baseline in CGI-Severity score [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Descriptive estimates of the persistence of safety events and adverse events [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	July 2004
Study Completion Date:	September 2004

Arms	Assigned Interventions
Placebo group: Placebo Comparator	Other: placebo Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).
Alprazolam XR group: Active Comparator	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.

Arms

Assigned Interventions

Placebo group: Placebo Comparator

Other: placebo

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

Alprazolam XR group: Active Comparator

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.

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.

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635076

Locations

United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6131007
Study First Received:	March 5, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00635076 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Panic Disorder
Tranquilizing Agents
Alprazolam
Anxiety Disorders

Mental Disorders
Hypnotics and Sedatives
Psychotropic Drugs
Central Nervous System Depressants
Anti-Anxiety Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Pharmacologic Actions
Panic Disorder

Pathologic Processes
Alprazolam
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009