Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial

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.

Timeline

Start

2010-07

Primary completion

2014-05

Completion

2014-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Sertraline and Mirtazapine vs Sertraline and Sugar Pill; p = 0.17; Mixed Models Analysis NCT01178671 ↗

registry analysis (superiority or other test); Sertraline and Mirtazapine vs Sertraline and Sugar Pill; p = 0.82; t-test, 2 sided NCT01178671 ↗

paper There were no significant group differences in the two primary outcomes of treatment retention and PTSD severity PMID 26115513 ↗

Publications

• Schneier FR, Campeas R, Carcamo J, Glass A, Lewis-Fernandez R, Neria Y, Sanchez-Lacay A, Vermes D, Wall MM. COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL. Depress Anxiety. 2015 Aug;32(8):570-9. doi: 10.1002/da.22384. Epub 2015 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirtazapine	Other / unclassified	45 mg	—
Subject	Sertraline	Small molecule	200 mg	—

Indications