title: COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: New York State Psychiatric Institute, New York, New York.|Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
authors.forename: Franklin R
authors.initials: FR
authors.lastname: Schneier
authors.affiliation: New York State Psychiatric Institute, New York, New York.|Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
authors.forename: Raphael
authors.initials: R
authors.lastname: Campeas
authors.affiliation: Hispanic Family Mental Health Center, Woodside, New York.
authors.forename: Jaime
authors.initials: J
authors.lastname: Carcamo
authors.affiliation: Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York.
authors.forename: Andrew
authors.initials: A
authors.lastname: Glass
authors.affiliation: New York State Psychiatric Institute, New York, New York.|Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
authors.forename: Roberto
authors.initials: R
authors.lastname: Lewis-Fernandez
authors.affiliation: New York State Psychiatric Institute, New York, New York.|Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
authors.forename: Yuval
authors.initials: Y
authors.lastname: Neria
authors.affiliation: New York State Psychiatric Institute, New York, New York.|Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
authors.forename: Arturo
authors.initials: A
authors.lastname: Sanchez-Lacay
authors.affiliation: New York State Psychiatric Institute, New York, New York.
authors.forename: Donna
authors.initials: D
authors.lastname: Vermes
authors.affiliation: New York State Psychiatric Institute, New York, New York.|Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.|Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York.
authors.forename: Melanie M
authors.initials: MM
authors.lastname: Wall
mesh_terms: D000328:Adult; D000929:Antidepressive Agents, Tricyclic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008803:Mianserin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D008875:Middle Aged; D000078785:Mirtazapine; D017063:Outcome Assessment, Health Care; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D020280:Sertraline / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000929:Antidepressive Agents, Tricyclic; D008803:Mianserin; D000078785:Mirtazapine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline
keywords: antidepressants; anxiety; combined treatment; norepinephrine; posttraumatic stress disorder; psychopharmacology; randomized clinical trial; serotonin