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A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Hialeah, Florida, 33013 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Panic Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- A primary DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on
the Mini International Neuropsychiatric Interview for Children and Adolescents

- At least an average of one 4-symptom panic attack per week over the last 4 weeks
prior to screening

- At least an average of one 4-symptom panic attack per week over the last 4 weeks
prior to baseline

- At least one 4-symptom panic attack in the 7 days prior to baseline

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder,
major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence

- Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress
disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder,
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 Axis I eating
disorder; mental retardation, Asperger's disorder, or any other serious developmental
disorder

- A CDRS-R score >35

NCT00635531
Pfizer
Terminated
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder
Brief SummaryThe purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with panic disorder
Detailed DescriptionDue 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE
  • Other: placebo
    Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam
  • Drug: alprazolam XR
    Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period.
    Other Name: Xanax XR
Study Arms  ICMJE
  • Placebo Comparator: Placebo group
    Intervention: Other: placebo
  • Active Comparator: Alprazolam XR group
    Intervention: Drug: alprazolam XR
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 5, 2008)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A primary DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents
  • At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening
  • At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline
  • At least one 4-symptom panic attack in the 7 days prior to baseline

Exclusion Criteria:

  • Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence
  • Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, 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 Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder
  • A CDRS-R score >35
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635531
Other Study ID Numbers  ICMJE A6131002
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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