At a glance
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Combined Mirtazapine and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment of Post-traumatic Stress Disorder (PTSD)
In Brief
A Phase 4 clinical trial evaluating Mirtazapine, Sertraline, and 1 other intervention for Posttraumatic Stress Disorder. Completed, enrolled 38 participants across 1 site.
Detailed Summary
The overall goal of this study is to examine the efficacy of the combination of mirtazapine and sertraline in the treatment of posttraumatic stress disorder (PTSD). Sertraline is FDA-approved for PTSD, but it is often not fully effective. The combination of mirtazapine and serotonin reuptake inhibitors like sertraline has appeared highly effective in a related disorder -- depression. In this study, sixty patients with chronic PTSD will be randomized to treatment with either sertraline + mirtazapine or sertraline + placebo for 12 weeks. Patients who show at least a minimal response after 12 weeks will continue for another 12 weeks on the same treatment.
Study Details
Timeline
Interventions
Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks