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A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients
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.
Details
| Lead sponsor | Indiana University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 150 |
| Start date | 2003-12 |
| Completion | 2007-09 |
Conditions
- Panic Disorder
Interventions
- Sertraline and Alprazolam XR
Primary outcomes
- Panic symptoms scale score
- CGI-I
- CGI-S
Countries
United States