A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00634790

Purpose

The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.

Condition	Intervention	Phase
Panic Disorder	Drug: alprazolam XR	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study to Assess the Safety and Tolerability of Xanax XR in the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks

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:

Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam [ Time Frame: 6 week taper ] [ Designated as safety issue: Yes ]
The incidence of treatment-emergent adverse event during treatment with alprazolam XR [ Time Frame: 24 weeks with taper ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Descriptive estimates of the persistence of safety events and adverse events at study endpoint [ Time Frame: 24 weeks with taper ] [ Designated as safety issue: Yes ]
Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Endpoint change from baseline to Week 24 in CGI-Severity score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	May 2004
Study Completion Date:	October 2004

Arms	Assigned Interventions
Active Comparator: alprazolam group	Drug: alprazolam XR Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days. Other Name: Xanax XR

Arms

Assigned Interventions

Active Comparator: alprazolam group

Drug: alprazolam XR

Alprazolam XR oral tablet 1 mg daily for 7 days; thereafter the daily dose will be titrated at a maximum rate of 1 mg every 7 days up to a maximum dose of 6 mg; dose adjustments up or down may be made, at a rate not to exceed 1 mg every 7 days; alprazolam XR will be administered for a total of 6 months followed by a gradual taper at a rate of 1 mg every 7 days.

Other Name: Xanax XR

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:

Subjects must meet one of the following 6 diagnoses: a. A current diagnosis of panic disorder with or without agoraphobia; b. Generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. Social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. Separation anxiety with a history of at least one panic attack in the course of their illness; e. Posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. Anxiety not otherwise specified with a history of at least one panic attack in the course of their illness.
Educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with.

Exclusion Criteria:

Current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence.
Current (in the past 3 months) diagnosis of alcohol and/or substance abuse.
Primary diagnosis of 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 eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder.
A Childhood Depression Rating Scale, Revised score >35.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634790

Show 47 Study Locations

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00634790 History of Changes
Other Study ID Numbers:	A6131004
Study First Received:	March 5, 2008
Last Updated:	April 7, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Panic Disorder
Anxiety Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012