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

Stopped early · Phase 4

Conditions studied: Panic Disorder

In brief

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.

Key facts

Study ID

NCT00634790

Run by

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

People needed

49

Starts

2004-05-01

Expected to finish

2004-10-01

Last updated by the study team

2021-01-28

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Little Rock, Alaska, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Burbank, California, United States
• Pfizer Investigational Site — El Centro, California, United States
• Pfizer Investigational Site — La Mesa, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Marcos, California, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Hialeah, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — North Miami, Florida, United States
• Pfizer Investigational Site — St. Petersburg, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — Boise, Idaho, United States
• Pfizer Investigational Site — Schaumburg, Illinois, United States
• Pfizer Investigational Site — Terre Haute, Indiana, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Owensboro, Kentucky, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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