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

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”

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.

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: alprazolam group

Primary Measures

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

Secondary Measures

• Descriptive estimates of the persistence of safety events and adverse events at study endpoint
  • Time Frame: 24 weeks with taper
    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
    Safety Issue?: No
• Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score
  • Time Frame: 24 weeks
    Safety Issue?: No
• Endpoint change from baseline to Week 24 in CGI-Severity score
  • Time Frame: 24 weeks
    Safety Issue?: No
• Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score
  • Time Frame: 24 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634790

Study ID Number: A6131004

ClinicalTrials.gov Identifier: NCT00634790

Health Authority: United States: Food and Drug Administration

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