Mirtazapine for patients with alcohol dependence and comorbid depressive disorders: A multicentre, open label study Su-Jung Yoon a , Chi-Un Pae b , Dai-Jin Kim c, ⁎ , Kee Namkoong d , Eun Lee e , Dong-Yul Oh f , Young-Sik Lee g , Dong-Hwan Shin h , Young-Cheol Jeong i , Joon-Hong Kim j , Sung-Bin Choi k , In-Bok Hwang l , Young-Chul Shin m , Sung-Nam Cho n , Hae Kook Lee o , Chung Tai Lee o a Department of Psychiatry, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea b Department of Psychiatry, Kangnam St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea c Department of Psychiatry, Holy Family Hospital, College of Medicine, The Catholic University of Korea, 2 Sosa-Dong, Buchon-City, Kunggi, 420-717, South Korea d Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea e Department of Psychiatry, Ilsan Hospital, National Health Insurance Corporation, Gyeonggi-do, Republic of Korea f Department of Psychiatry, Myongji Hospital, Kwandong University, Republic of Korea g Department of Neuropsychiatry, Chungang University, Medical School, Seoul, Republic of Korea h Hong Seong Medical Center, Republic of Korea i Bae Sung Hospital, Republic of Korea j Dr. Kim's psychiatric, Republic of Korea k Keyo Hospital, Republic of Korea l Dasarang Alcohol Hospital, Republic of Korea m Department of Psychiatry, Sung Kyun Kwan University, KangBuk Samsung Hospital, Seoul, Republic of Korea n National Bugok Hospital, Republic of Korea o Department of Psychiatry, Uijongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea Available online 19 April 2006 Abstract Major depressive disorder and alcohol dependence are common and serious mental illnesses. There is a great interest in discovering useful treatments for both mood symptoms and alcohol abuse in those patients with depressive disorders and comorbid alcohol dependence. The primary purpose of this study was to evaluate the effectiveness and tolerability of mirtazapine for the treatment of patients with alcohol dependence comorbid with a depressive disorder in an open label, naturalistic multicentre treatment setting. The 17-item Hamilton Depression Rating Scale (HDRS), the Hamilton Anxiety Rating Scale (HARS) and the Clinical Global Impression-Severity (CGI-S) scale were measured at baseline and at weeks 4 and 8 for the assessment of treatment effectiveness. Alcohol craving was measured using the Obsessive Compulsive Drinking Scale (OCDS) and the Visual Analog Scale for Craving (VAS). This study showed a statistically significant reduction of the scores on the HDRS (13.9±7.3, p b 0.0001), HARS (10.8 ± 7.2, p b 0.0001) and the CGI-S (1.7 ± 1.0, p b 0.0001) from baseline to the endpoint (week 8). The OCDS and VAS scores were also decreased significantly by 42.3% and 53.2% (9.0 ± 10.0, p b 0.0001; 2.5 ± 2.4, p b 0.0001, respectively). The number of patients with a 50% reduction or more in the HDRS and HARS scores was 103 (72.0%) and 106 (74.1%) at the endpoint, respectively. Adverse events related to mirtazapine were observed in 10% or more of the patients in this study. In conclusion, the results from this naturalistic study suggest that the use of mirtazapine for the patients with alcohol dependence comorbid with depressive disorder is accompanied by clinical improvement in their mood and alcohol craving. © 2006 Elsevier Inc. All rights reserved. Keywords: Alcohol dependence; Craving; Depressive disorder; Mirtazapine 1. Introduction Major depressive disorder and alcohol dependence are common and serious mental illnesses; they have a lifetime prevalence of 4.25% and 10.20% in Koreans, respectively (Cho Progress in Neuro-Psychopharmacology & Biological Psychiatry 30 (2006) 1196 – 1201 www.elsevier.com/locate/pnpbp Abbreviations: CGI-S, Clinical Global Impression-Severity; HDRS, Hamil- ton Depression Rating Scale; HARS, Hamilton Anxiety Rating Scale; ITT, Intent-to-treat population; LOCF, Last observation carried forward; OCDS, Obsessive Compulsive Drinking Scale; VAS, Visual Analog Scale for Craving. ⁎ Corresponding author. Tel.: +82 32 340 2140; fax: +82 32 340 2670. E-mail address: kdj922@chollian.net (D.-J. Kim). 0278-5846/$ - see front matter © 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.pnpbp.2006.02.018