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A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients

NCT00198094 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2007-10-22

No results posted yet for this study

Summary

The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.

Conditions

  • Panic Disorder

Interventions

DRUG

Sertraline and Alprazolam XR

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Pennsylvania

    collaborator OTHER

  • University of South Florida

    collaborator OTHER

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Andrew W Goddard, M.D. · Indiana University

  • Karl Rickles, M.D. · University of Pennsylvania

  • David Sheehan, M.D., M.B.A. · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Completion
2007-09-30

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 NCT00198094 on ClinicalTrials.gov