Efficacy and Safety of Aripiprazole during Acute Treatment Phase in Patients with Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder: An 8-Week, Prospective, Open-Label Study

Efficacy and Safety of Aripiprazole during Acute Treatment Phase in Patients with Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder:An 8-Week, Prospective, Open-Label Study Jung-Seok Choi, MD, Do Hoon Kim, MD, PhD, Yong Ku Kim, MD, Jeong Gee Kim, MD, PhD, Won-Myong Bahk, MD, PhD, Jae Gong Cyn, MD, Bo Hyun Yoon, MD, Jung Goo Lee, MD, PhD, Duk-In Jon, MD, PhD, Young Chul Chung, MD, PhD, Tak Youn, MD, PhD and Jun Soo Kwon, MD, PhD Department of Psychiatry, Seoul National University College of Medicine, Seoul, Department of Psychiatry, Hallym University College of Medicine, Chuncheon Sacred Heart Hospital, Chuncheon, Department of Psychiatry, Ansan Hospital, Korea University College of Medicine, Ansan, Department of Neuropsychiatry, Maryknoll General Hospital, Busan, Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Department of Psychiatry, Yong-In Mental Hospital, Yongin, Department of Psychiatry, Naju National Hospital, Naju, Paik Institute for Clinical Research, Inje University, Busan, Department of Psychiatry, Hallym University College of Medicine, Anyang, Department of Psychiatry, Chonbuk National University College of Medicine, Jeonju, Department of Psychiatry, Chonnam National University Medical School, Gwangju, Korea Objective:The purpose of the present study was to investigate the efficacy, safety, and tolerability of aripiprazole in patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder during acute treatment phase. Methods:Prospective, multicenter, single group, and 8-week study was conducted in patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder. A total of 300 patients were enrolled in the present study. The primary efficacy measure was the Positive and Negative Syndrome Scale (PANSS) total score, and secondary efficacy measures were the PANSS positive and negative subscales scores, and Clinical 접수일:2008년 4월 15일 / 수정일:2008년 5월 2일 / 게재확정일:2008년 5월 8일 This study was supported by Korea Otsuka Pharmaceutical Co., Ltd (Seoul, Korea). 교신저자:권준수, 110-744 서울 종로구 연건동 28번지 서울대학교 의과대학 정신과학교실 전화:(02) 2072-2972·전송:(02) 747-9063 E-mail:kwonjs@plaza.snu. ac.kr 아리피프라졸의 정신분열병 급성기 치료 Korean J Psychopharmacol 2008;19(3):147-155 148 Global Impression-Severity of Illness (CGI-S) score. Treatment-emergent adverse events, extrapyramidal symptoms (EPS), weight, vital signs, and laboratory tests were assessed as measures of tolerability and safety. Results: Significant improvements in all efficacy measures were achieved by aripiprazole as early as 1-week and sustained through 8-week period. First-episode patients showed greater improvements in PANSS total, positive subscale score, and CGI-S score, compared with recurrent patients. Slightly increased akathisia (+0.32 from baseline score of Barnes Akathisia Rating Scale, p=0.033) and weight gain (1.15±3.44 kg, p<0.001) were observed by aripiprazole during 8-week acute treatment phase. Conclusion:The present study demonstrated that aripiprazole was effective in acute treatment of positive and negative symptoms of schizophrenia, schizophreniform disorder, and schizoaffective disorder. In general, aripiprazole showed favorable safety and tolerability profiles, although clinicians needed to pay attention to the possibility of akathisia and weight gain by aripiprazole in first-episode patients during acute treatment phase. (Korean J Psychopharmacol 2008;19(3):147-155)