A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) 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 long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in adolescents with panic disorder.
Key facts
- Study ID
- NCT00635076
- Run by
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- People needed
- 3
- Starts
- 2004-07-01
- 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 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Eugene, Oregon, United States
- Pfizer Investigational Site — San Antonio, Texas, United States
- Pfizer Investigational Site — Middleton, Wisconsin, United States
Full record on ClinicalTrials.gov
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