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

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Little Rock, Alaska, 72223 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

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

- 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.

NCT00634790
Pfizer
Terminated
A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks

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Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief SummaryThe 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.
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE 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
Study Arms  ICMJE Active Comparator: alprazolam 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)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
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 NCT00634790
Other Study ID Numbers  ICMJE A6131004
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

FOR MORE INFORMATION

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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