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

NCT00635531 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-01-28

No results posted yet for this study

Summary

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

Conditions

  • Panic Disorder

Interventions

OTHER

placebo

Placebo dosing same as alprazolam, except a placebo equivalent was substituted for alprazolam

DRUG

alprazolam XR

Oral treatment started at a daily dose of 1 mg tablets for the first 7 days; thereafter the daily dosage was titrated at a maximum rate of 1 mg every 7 days up to a maximum dosage of 6 mg for lack of response, and in the absence of dose-limiting adverse events; no further increases in daily dose were permitted after Day 36; dosage reductions were permitted if required for tolerability; subjects who were not eligible for entry into the 18-week continuation study, or who were eligible but elected not to participate, were tapered off study drug at a rate of 1 mg every 7 days for up to a 6-week taper period.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2004-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635531 on ClinicalTrials.gov