A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2004-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).

Alprazolam XR group

Group Type ACTIVE_COMPARATOR

alprazolam XR

Intervention Type DRUG

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.

Interventions

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placebo

Patients continued taking the matching placebo that they were taking when they completed Study A6131002 (oral tablets taken once daily).

Intervention Type OTHER

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.

Intervention Type DRUG

Other Intervention Names

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Xanax XR

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No