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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, United States
University Hospital Outpatient Center, Psychiatry
Indianapolis, Indiana, United States
University of Pennsylvania, Mood and Anxiety Disorders Section
Philadelphia, Pennsylvania, United States
Panic symptoms scale score
CGI-I
CGI-S
Sheehan Disability Scale
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