Human psychopharmacology · 2004
Efficacy and tolerability of mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label trial.
Клиническое исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Chung Moon Yong, Min Kyung Ho, Jun Yong Ju, Kim Sung Soo, Kim Wan Chul, Jun Eun Mi
Аннотация
BACKGROUND: The aim of this study was to investigate the potential use of mirtazapine in Korean veterans diagnosed with PTSD, by comparing it with sertraline, a drug approved for use in PTSD in the USA.
METHODS: Efficacy was evaluated by the clinician administered PTSD scale (CAPS-2), the Hamilton rating scale for depression (HAMD-17) and the clinical global impression scale (CGI), at baseline and at weeks 1, 2 and 6. A response was defined as a > or = 30 % decrease in CAPS-2 total severity, a > or = 50 % decrease in total HAMD-17 score, and a CGI-I score < 3.
RESULTS: 51 patients on mirtazapine (mean age/duration of illness: 59.1/33.5 years) and 49 on sertraline (mean age/duration of illness: 60.6/35.6 years) completed the study. The mean daily dosage was 34.1 mg for mirtazapine and 101.5 mg for sertraline. On the CAPS-2 total score more patients responded in the mirtazapine group at week 1 (13 vs 2 %) and week 2 (51 vs 31 %). At week 6 this difference was statistically significant (88 % vs 69 %, p = 0.039) on the CAPS-2 total score. The HAMD-17 total score and CGI-I score decreased in both groups, with no significant differences between th groups on all time points. The main side effects for the mirtazapine group were: dry mouth (19.6 %), constipation (19.6 %), somnolence (15.7 %) and weight gain (1.96 %); and for the sertraline group: indigestion (14.3 %), palpitation (6.1 %), agitation (2.0 %), epigastric soreness (2.0 %), insomnia (2.0 %) and sexual dysfunction (2.0 %).
CONCLUSION: Mirtazapine appeared to be an effective and well-tolerated treatment for PTSD in Korean veterans.
METHODS: Efficacy was evaluated by the clinician administered PTSD scale (CAPS-2), the Hamilton rating scale for depression (HAMD-17) and the clinical global impression scale (CGI), at baseline and at weeks 1, 2 and 6. A response was defined as a > or = 30 % decrease in CAPS-2 total severity, a > or = 50 % decrease in total HAMD-17 score, and a CGI-I score < 3.
RESULTS: 51 patients on mirtazapine (mean age/duration of illness: 59.1/33.5 years) and 49 on sertraline (mean age/duration of illness: 60.6/35.6 years) completed the study. The mean daily dosage was 34.1 mg for mirtazapine and 101.5 mg for sertraline. On the CAPS-2 total score more patients responded in the mirtazapine group at week 1 (13 vs 2 %) and week 2 (51 vs 31 %). At week 6 this difference was statistically significant (88 % vs 69 %, p = 0.039) on the CAPS-2 total score. The HAMD-17 total score and CGI-I score decreased in both groups, with no significant differences between th groups on all time points. The main side effects for the mirtazapine group were: dry mouth (19.6 %), constipation (19.6 %), somnolence (15.7 %) and weight gain (1.96 %); and for the sertraline group: indigestion (14.3 %), palpitation (6.1 %), agitation (2.0 %), epigastric soreness (2.0 %), insomnia (2.0 %) and sexual dysfunction (2.0 %).
CONCLUSION: Mirtazapine appeared to be an effective and well-tolerated treatment for PTSD in Korean veterans.