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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 December 17, 2017

FOR MORE INFORMATION
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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A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Panic Disorder
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
Active Comparator: alprazolam group
Intervention: Drug: alprazolam XR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
October 2004
Not Provided

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.
Sexes Eligible for Study: All
13 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00634790
A6131004
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

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

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