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COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO‐CONTROLLED TRIAL
Author(s) -
Schneier Franklin R.,
Campeas Raphael,
Carcamo Jaime,
Glass Andrew,
LewisFernandez Roberto,
Neria Yuval,
SanchezLacay Arturo,
Vermes Donna,
Wall Melanie M.
Publication year - 2015
Publication title -
depression and anxiety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.634
H-Index - 129
eISSN - 1520-6394
pISSN - 1091-4269
DOI - 10.1002/da.22384
Subject(s) - sertraline , mirtazapine , tolerability , placebo , serotonin reuptake inhibitor , medicine , randomized controlled trial , psychology , antidepressant , psychiatry , anesthesia , adverse effect , anxiety , alternative medicine , pathology
Background Combined treatment with a selective serotonin reuptake inhibitor (SSRI) plus mirtazapine has shown superior efficacy in some studies of depression, but has not been studied in posttraumatic stress disorder (PTSD). This study aimed to assess acceptability of combined sertraline plus mirtazapine treatment for PTSD and to estimate its effect size relative to sertraline plus placebo. Methods Thirty‐six adults with PTSD were randomized to 24 weeks of double‐blind treatment with sertraline plus mirtazapine or sertraline plus placebo. Outcomes were analyzed with mixed effects models. Results The combined treatment group showed a significantly greater remission rate ( P = .042) and improvement in depressive symptoms ( P = .023) than the sertraline plus placebo group. There were no significant group differences in the two primary outcomes of treatment retention and PTSD severity, or in other secondary outcomes (sleep impairment, sexual functioning, quality of life, and physical and mental functioning), but the combined treatment group showed numerical advantages on all of these outcomes, and effect sizes relative to sertraline plus placebo ranged from small to moderate ( d = .26–.63). Both treatments were well‐tolerated, with significantly increased appetite but not weight gain in the combined treatment group. Conclusion Findings suggest that combined treatment of PTSD with sertraline plus mirtazapine may have clinically meaningful advantages in symptomatic improvement, relative to SSRI treatment alone, and acceptable tolerability. Combined treatment with an SSRI plus mirtazapine in PTSD deserves additional study as initial treatment or as an augmentation strategy for nonresponders to an SSRI.