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A prospective, open-label study to evaluate symptomatic remission in schizophrenia with risperidone long-acting injectable in Korea

Lee, Nam Younga,b; Kim, Se Hyunf; Cho, Seong Jinm; Chung, Young-Choc; Jung, In Kwai; Kim, Chang Yoonj; Kim, Duk Hon; Lee, Dong Geund; Lee, Yo Hano; Lim, Weon Jeongk; Na, Young Suke; Shin, Sang Eunq; Woo, Jong-Minl; Yoon, Jin Sangp; Yoon, Bo-Hyunr; Ahn, Yong Minf,g,h; Kim, Yong Sika,g

International Clinical Psychopharmacology: September 2014 - Volume 29 - Issue 5 - p 279–287
doi: 10.1097/YIC.0000000000000030
Original Articles

This study was designed to investigate long-term clinical outcomes of risperidone long-acting injectable (RLAI) in patients with schizophrenia or schizoaffective disorder. An open-label, 48-week, prospective study of RLAI treatment was carried out at 63 centers in South Korea. Initial and maintenance dosage of RLAI were adjusted according to clinical judgment. Efficacy was measured by the remission rate, continuation rate, and changes in the clinical measurements such as eight items of the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression – Severity, and the Schizophrenia Quality of Life Scale. In terms of the safety, Simpson-Angus rating Scale, adverse events (AEs), and BMI were investigated. Of the 522 patients who were enrolled, 472 patients who had been assessed on the eight items of PANSS at baseline and at least once during RLAI treatment were included in the intention-to-treat (ITT) population. The per-protocol (PP) population included 184 patients (39.0%), who completed all assessments during 48 weeks of the follow-up period. Total scores of eight items of PANSS, Clinical Global Impression – Severity, and Schizophrenia Quality of Life Scale were reduced significantly from baseline to endpoint in both ITT and PP populations. The mean dose (SD) of RLAI was 33.2 (7.6) mg. In the PP population, the number of patients who scored 1–3 on eight items of PANSS were 47 (25.5%) at baseline and 144 (78.3%) at 48 weeks. According to the remission defining as scores 1–3 on eight items of PANSS sustaining of at least 6 months’ duration by Andreasen, the numbers of patients who achieved remission were 45 (24.5%) at 24 weeks and 120 (65.2%) at 48 weeks. A significant decrease in the mean score of Simpson-Angus rating Scale and a significant increase in BMI over time in last observation carried forward were observed, and patients who fulfilled the remission criteria during the study showed more weight gain than those who did not. During the study period, a total of 645 AEs were noted in 233 patients (49.3%) who were included in the ITT population. Sixty-nine serious AEs in 51 patients were reported, but all of them were not directly attributable to administration of RLAI. This prospective, open-label study showed improvements in symptom and AEs and a significant increase in BMI during 48 weeks of biweekly RLAI treatment. The rate of study completion was 39.0% and the remission rate among those who completed the study was 65.2%. None of the serious AEs were directly related to the administration of RLAI.

aDepartment of Neuropsychiatry, Dongguk University International Hospital

bDepartment of Neuropsychiatry, Dongguk University College of Medicine

cDepartment of Psychiatry, Inje University Ilsan Paik Hospital

dMaumpeunhan Psychiatry

ePuremind Psychiatry, Gyeonggi-do

fInstitute of Human Behavioral Medicine, Seoul National University Medical Research Center

gDepartment of Psychiatry and Behavioral Science, Seoul National University College of Medicine

hDepartment of Neuropsychiatry, Seoul National University Hospital

iDepartment of Neuropsychiatry, Korea University Guro Hospital

jDepartment of Neuropsychiatry, Asan Medical Center

kDepartment of Neuropsychiatry, Ewha Womans University Mokdong Hospital

lDepartment of Psychiatry, Inje University Seoul Paik Hospital, Seoul

mDepartment of Psychiatry, Gachon University Gil Hosptial, Incheon

nSanulrim Hospital, Gyeongbuk

oDepartment of Neuropsychiatry, St John of God Hospital

pDepartment of Psychiatry, Chonnam National University Hospital, Gwangju

qDepartment of Psychiatry, Seoul Metropolitan Eunpyeong Hospital, Eunpyeong-gu

rNaju National Hospital, Jeollanam-do, Korea

Clinical Trials Registration: Available at: http://clinicaltrials.gov/ct2/show/study/NCT00216528

Correspondence to Yong Sik Kim, MD, PhD, Department of Neuropsychiatry, Dongguk University International Hospital, 27 Dongguk-Ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 410-773, Korea Tel: +82 31 961 7235; fax: +82 31 961 9236; e-mail: kys@snu.ac.kr

Received June 15, 2013

Accepted January 14, 2014

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins