A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Indiana University School of Medicine
Collaborators:
Pfizer University of Pennsylvania University of South Florida