Rash in adult patients receiving lamotrigine to treat bipolar I disorder in Korea: A multicenter, prospective, naturalistic, open-label trial Young Sup Woo a , Won-Myong Bahk a, ⁎, Duk-In Jon b , Yeon Ho Joo c , Won Kim d , Jeong Seok Seo e , Yong Min Ahn f , Sang-Keun Chung g , Seung-Hee Won h , Young Chul Shin i , Bo-Hyun Yoon j , Sung-Hun Jung k , Jeong Ho Seok b , Yil-Seob Lee l , Yooni Kim l , Kyung Joon Min m a Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea b Department of Psychiatry, College of Medicine, Hallym University, Anyang, Republic of Korea c Department of Psychiatry, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea d Department of Psychiatry and Stress Research Institute, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, Republic of Korea e Department of Psychiatry, College of Medicine, Konkuk University, Cheongju, Republic of Korea f Department of Psychiatry, Seoul National University Hospital, Seoul, Republic of Korea g Department of Psychiatry, Chonbuk National University Medical School, Jeonju, Republic of Korea h Department of Psychiatry, College of Medicine, Catholic University of Daegu, Daegu, Republic of Korea i Department of Psychiatry, Kangbuk Samsung Hospital, School of Medicine, Sungkyunkwan University, Seoul, Republic of Korea j Department of Psychiatry, Naju National Hospital, Naju, Republic of Korea k Department of Psychiatry, College of Medicine, Kyungpook National University, Daegu, Republic of Korea l GlaxsoSmithKleine Korea Pharmaceuticals, Seoul, Republic of Korea m Department of Neuropsychiatry, College of Medicine, Chung-Ang University, Seoul, Republic of Korea abstract article info Article history: Received 19 January 2009 Received in revised form 18 May 2009 Accepted 11 June 2009 Available online 18 June 2009 Keywords: Bipolar I disorder Lamotrigine Rash The goal of this study was to assess the incidence of rash occurring in patients received lamotrigine to treat bipolar I disorder in a real world setting in Korea. We included a heterogeneous sample with multiple medications and medical comorbidities. Lamotrigine was added to the current therapy regime for DSM-IV bipolar I patients on an open-label basis for 12 weeks. The incidences of rash and other adverse events were assessed. The primary outcome measure was the incidence of rash. A total of 237 adult patients were included in the present study and 173 patients (73.0%) completed the 12 weeks of treatment. Thirty patients (12.7%) developed a rash, of whom 2 (0.8%) developed a serious rash. There were no patients who developed Stevens-Johnson syndrome or toxic epidermal necrolysis. The median time of rash onset was 16 days. As a group, patients who did not experience rash were significantly heavier than those who did. Our findings suggest that the incidence of serious rash associated with lamotrigine is low. The prescription of lamotrigine should be undertaken with appropriate consideration of the potential risk of adverse events including rash to the patient in relation to potential benefit from improvement of bipolar disorder. © 2009 Published by Elsevier Inc. 1. Introduction Bipolar disorder is a chronic, debilitating illness. A major assess- ment of the global burden of this disease and risk factors has ranked bipolar disorder among the top 10 disabling disorders in both developed and developing countries (Mathers et al., 2006). Although bipolar disorder is defined by a history of manic or hypomanic episodes, depressive symptoms are the predominant mood symptoms expressed in patients with bipolar disorder. Indeed, bipolar patients have clinically significant depressive symptoms for about three times longer than manic symptoms (Judd et al., 2002, 2003). Despite the magnitude of these problems, treatments for bipolar depression are much less well defined than those for mania. Although conventional mood stabilizers have been used for bipolar depression, their antidepressant effects have not been well established with the exception of lithium (Thase and Sachs, 2000). Lithium has been studied most extensively; most of the early double-blind studies documented significant antidepressant effects compared to placebo (Thase and Sachs, 2000). However, because bipolar disorder requires prolonged and comprehensive treatment to prevent relapse or recurrence, adverse effects and the low therapeutic index of lithium treatment reduce its viability in this context. Atypical antipsychotics such as olanzapine combination with fluoxetine and quetiapine Progress in Neuro-Psychopharmacology & Biological Psychiatry 33 (2009) 1147–1152 Abbreviations: CGI-BP-S, Clinical Global Impression-Bipolar version-Severity; LOCF, last observation carried forward; BMI, body mass index. ⁎ Corresponding author. Department of Psychiatry, College of Medicine, The Catholic University of Korea, #62 Yoido-Dong, Youngdeungpo-Gu, Seoul, 150-713, Republic of Korea. Tel.: +82 2 37791250; fax: +82 2 780 6577. E-mail address: wmbahk@catholic.ac.kr (W.M. Bahk). 0278-5846/$ – see front matter © 2009 Published by Elsevier Inc. doi:10.1016/j.pnpbp.2009.06.010 Contents lists available at ScienceDirect Progress in Neuro-Psychopharmacology & Biological Psychiatry journal homepage: www.elsevier.com/locate/pnp