A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Panic Disorder

In brief

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of alprazolam extended release (XR) for the treatment of adolescents with panic disorder

Key facts

Study ID

NCT00635531

Run by

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

People needed

16

Starts

2004-04-01

Expected to finish

2004-09-01

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…

• A primary DSM-IV-TR diagnosis of panic disorder with or without agoraphobia based on the Mini International Neuropsychiatric Interview for Children and Adolescents
• At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to screening
• At least an average of one 4-symptom panic attack per week over the last 4 weeks prior to baseline
• At least one 4-symptom panic attack in the 7 days prior to baseline

You may not qualify if…

• Current (in the past 6 months) DSM-IV-TR diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence
• Primary DSM-IV-TR diagnosis of social anxiety disorder, post-traumatic stress disorder, simple phobia, separation anxiety disorder, generalized anxiety disorder, 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 Axis I eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder
• A CDRS-R score >35

Where it is running

• 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 — Boise, Idaho, United States
• Pfizer Investigational Site — Terre Haute, Indiana, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Saint Paul, Minnesota, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — Lyndhurst, Ohio, United States
• Pfizer Investigational Site — Eugene, Oregon, United States
• Pfizer Investigational Site — Media, Pennsylvania, United States
• Pfizer Investigational Site — Columbia, South Carolina, United States
• Pfizer Investigational Site — Lake Jackson, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Wichita Falls, Texas, United States
• Pfizer Investigational Site — Bellevue, Washington, United States
• Pfizer Investigational Site — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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