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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

NCT ID: NCT00634790

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Panic Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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alprazolam group

Group Type ACTIVE_COMPARATOR

alprazolam XR

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Xanax XR

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Little Rock, Alaska, United States

Site Status

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Burbank, California, United States

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El Centro, California, United States

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La Mesa, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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San Marcos, California, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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North Miami, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Decatur, Georgia, United States

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Boise, Idaho, United States

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Schaumburg, Illinois, United States

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Terre Haute, Indiana, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Owensboro, Kentucky, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Clinton Township, Michigan, United States

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Saint Paul, Minnesota, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Clementon, New Jersey, United States

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Kenilworth, New Jersey, United States

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Morristown, New Jersey, United States

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Bismarck, North Dakota, United States

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Cleveland, Ohio, United States

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Lyndhurst, Ohio, United States

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Eugene, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Media, Pennsylvania, United States

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Columbia, South Carolina, United States

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Selmer, Tennessee, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Midlothian, Virginia, United States

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Richmond, Virginia, United States

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Pfizer Investigational Site

Middleton, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6131004&StudyName=A%20Study%20To%20Assess%20the%20Safety%20of%20Extended%20Release%20Alprazolam%20for%20the%20Treatment%20of%20Adolescents%20with%20Panic%20Disorder%20or%20Anxiety%20with%20Pan

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6131004

Identifier Type: -

Identifier Source: org_study_id

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