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| Sponsors and Collaborators: |
Indiana University School of Medicine Pfizer University of Pennsylvania University of South Florida |
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00198094 |
Purpose
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.
| Condition | Intervention | Phase |
|
Panic Disorder |
Drug: Sertraline and Alprazolam XR |
Phase IV |
| MedlinePlus related topics: | Anxiety Panic Disorder |
| ChemIDplus related topics: | Sertraline hydrochloride Sertraline Alprazolam |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |||||
| University of South Florida, Department of Psychiatry and Behavioral Medicine | |||||
| Tampa, Florida, United States, 33613 | |||||
| United States, Indiana | |||||
| University Hospital Outpatient Center, Psychiatry | |||||
| Indianapolis, Indiana, United States, 46202 | |||||
| United States, Pennsylvania | |||||
| University of Pennsylvania, Mood and Anxiety Disorders Section | |||||
| Philadelphia, Pennsylvania, United States, 19104-3309 | |||||
| Indiana University School of Medicine |
| Pfizer |
| University of Pennsylvania |
| University of South Florida |
| Principal Investigator: | Andrew W Goddard, M.D. | Indiana University |
| Principal Investigator: | Karl Rickles, M.D. | University of Pennsylvania |
| Principal Investigator: | David Sheehan, M.D., M.B.A. | University of South Florida |
More Information
| Study ID Numbers: | 0311-34, IU 1003 |
| First Received: | September 12, 2005 |
| Last Updated: | October 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00198094 |
| Health Authority: | United States: Institutional Review Board |
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