Mirtazapine monotherapy not effective treatment option for PTSD: Study
Alabama: Mirtazapine monotherapy does not appear to be effective for PTSD treatment, finds a recent study in the Journal of Clinical Psychiatry.
The aim of this study by Lori L. Davis, the Research and Development Service at VA Medical Center in Alabama, and colleagues was to determine the efficacy of mirtazapine, a tetracyclic antidepressant, as monotherapy for posttraumatic stress disorder (PTSD) treatment.
The multisite, randomized, double-blind, placebo-controlled trial was conducted between April 2006 and November 2010 at the Tuscaloosa and Birmingham Veterans Affairs Medical Centers in Alabama. It included 77 US military veterans who met DSM-IV criteria for PTSD. They were randomly assigned to receive either placebo (n = 39) or mirtazapine (n = 39) titrated up to 45 mg/d for an 8-week double-blind period followed by an 8-week open-label phase of mirtazapine treatment.
The primary outcome efficacy measure was the Structured Interview for Posttraumatic Stress Disorder (SIP). Secondary measures included other measures of PTSD, depression, and sleep.
Key findings of the study include:
- No significant differences were observed between groups on the primary outcome of SIP scores during the controlled phase.
- In secondary outcomes, significant improvements per the Clinical Global Impressions–Improvement scale were found for the mirtazapine group compared to the placebo group.
- The 8-week open-label phase demonstrated significant symptom improvement in SIP total score and in scores on the SIP re-experiencing, avoidance, and hyperarousal subscales.
- There were no significant differences in the occurrence of adverse events between groups.
"Results of the study did not show efficacy of mirtazapine monotherapy in PTSD treatment. Identification of more effective treatments, either as monotherapy or adjunctive, for PTSD is imperative,"concluded the authors.
"A Randomized, Placebo-Controlled Trial of Mirtazapine for the Treatment of Posttraumatic Stress Disorder in Veterans," is published in the Journal of Clinical Psychiatry.