drugset / Trial / NCT01178671
Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
Phase 4
Completed
38 enrolled
Research Foundation for Mental Hygiene, Inc.
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirtazapine | Other / unclassified | 45 mg | — |
| Subject | Sertraline | Small molecule | 200 mg | — |