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A Study to Assess the Long-Term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Eugene, Oregon, 97401 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.
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- A primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
Revision diagnosis of panic disorder with or without agoraphobia based on the
Mini-International Neuropsychiatric Interview for Children and Adolescents

- Subjects with an average of 1) at least one 4-symptom panic attack per week over the
last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over
the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7
days prior to baseline

- To enter Study A6131007, subjects must have completed Study A6131002, had an
acceptable tolerability to study drug, and in the clinical judgment of the
investigator, could have benefited from continued study treatment.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects must continue to meet all of the exclusion criteria enumerated in the Acute
Efficacy Study (Protocol A6131002) with the following exception: Subjects will be
allowed to undergo cognitive-behavioral or other panic-specific therapy and any other
psychotherapy (e.g., supportive and/or family therapy) during the expected study
period in this study.

NCT00635076
Pfizer
Terminated
A Study to Assess the Long-Term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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