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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00635076
Recruitment Status : Terminated (Please see Detailed Description for the termination reason.)
First Posted : March 13, 2008
Last Update Posted : April 10, 2008
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Panic Disorder Other: placebo Drug: alprazolam XR Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder
Drug Information available for: Alprazolam

Arm Intervention/treatment
Placebo Comparator: Placebo group Other: placebo
Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).

Active Comparator: Alprazolam XR group Drug: alprazolam XR
Patients continued taking the same dosage of alprazolam that they were taking when they completed Study A6131002 (oral tablets taken once daily (1-6mg)); patients taking less than 6 mg/day who failed to show a satisfactory clinical response since the previous visit, and who were free of dose-limiting adverse events, could have their dosage titrated upward by 1 mg/day; upward daily dosage titration of 1 mg was allowed every 7 days, up to a maximum daily dosage of 6 mg/day; patients who were unable to tolerate the previous dosage level of alprazolam XR could have their daily dosage reduced.
Other Name: Xanax XR

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Endpoint change from baseline in Hamilton Anxiety Rating scale [ Time Frame: Weeks 12 and 24 ]
  2. Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores [ Time Frame: Weeks 12 an 24 ]
  3. Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale [ Time Frame: Weeks 12 and 24 ]
  4. Endpoint change compared with baseline in CGI-Severity score [ Time Frame: Weeks 12 and 24 ]
  5. Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score [ Time Frame: Weeks 12 and 24 ]
  6. Descriptive estimates of the persistence of safety events and adverse events [ Time Frame: Week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00635076

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United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00635076    
Other Study ID Numbers: A6131007
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Panic Disorder
Anxiety Disorders
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action