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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
This study has been terminated.
( Please see Detailed Description for the termination reason. )
Study NCT00635076   Information provided by Pfizer
First Received: March 5, 2008   Last Updated: April 7, 2008   History of Changes

March 5, 2008
April 7, 2008
July 2004
 
  • Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam [ Time Frame: Week 24 (taper baseline), Weeks 25-29, and end of taper visit ] [ Designated as safety issue: No ]
  • The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR [ Time Frame: Weeks 6, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00635076 on ClinicalTrials.gov Archive Site
  • Endpoint change from baseline in Hamilton Anxiety Rating scale [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores [ Time Frame: Weeks 12 an 24 ] [ Designated as safety issue: No ]
  • Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Endpoint change compared with baseline in CGI-Severity score [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Descriptive estimates of the persistence of safety events and adverse events [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
 
A Study to Assess the Long-Term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder
A Randomized, Double-Blind, Placebo-Controlled Study of Continuation Treatment With Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Panic Disorder
  • Other: placebo
  • Drug: alprazolam XR
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
3
September 2004
 

Inclusion Criteria:

  • 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:

  • 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.
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00635076
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A6131007
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP