PMID- 24583566 OWN - NLM STAT- MEDLINE DCOM- 20150407 LR - 20140805 IS - 1473-5857 (Electronic) IS - 0268-1315 (Linking) VI - 29 IP - 5 DP - 2014 Sep TI - A prospective, open-label study to evaluate symptomatic remission in schizophrenia with risperidone long-acting injectable in Korea. PG - 279-87 LID - 10.1097/YIC.0000000000000030 [doi] AB - 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. FAU - Lee, Nam Young AU - Lee NY AD - 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. FAU - Kim, Se Hyun AU - Kim SH FAU - Cho, Seong Jin AU - Cho SJ FAU - Chung, Young-Cho AU - Chung YC FAU - Jung, In Kwa AU - Jung IK FAU - Kim, Chang Yoon AU - Kim CY FAU - Kim, Duk Ho AU - Kim DH FAU - Lee, Dong Geun AU - Lee DG FAU - Lee, Yo Han AU - Lee YH FAU - Lim, Weon Jeong AU - Lim WJ FAU - Na, Young Suk AU - Na YS FAU - Shin, Sang Eun AU - Shin SE FAU - Woo, Jong-Min AU - Woo JM FAU - Yoon, Jin Sang AU - Yoon JS FAU - Yoon, Bo-Hyun AU - Yoon BH FAU - Ahn, Yong Min AU - Ahn YM FAU - Kim, Yong Sik AU - Kim YS LA - eng SI - ClinicalTrials.gov/NCT00216528 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - England TA - Int Clin Psychopharmacol JT - International clinical psychopharmacology JID - 8609061 RN - 0 (Antipsychotic Agents) RN - 0 (Drug Implants) RN - L6UH7ZF8HC (Risperidone) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Antipsychotic Agents/administration & dosage/adverse effects/*therapeutic use MH - Diagnostic and Statistical Manual of Mental Disorders MH - Drug Implants MH - Drug Monitoring MH - Female MH - Follow-Up Studies MH - Humans MH - Intention to Treat Analysis MH - Male MH - Middle Aged MH - Patient Dropouts MH - Psychiatric Status Rating Scales MH - Psychotic Disorders/*drug therapy/physiopathology/psychology MH - Quality of Life MH - Republic of Korea MH - Risperidone/administration & dosage/adverse effects/*therapeutic use MH - Schizophrenia/*drug therapy/physiopathology MH - Schizophrenic Psychology MH - Severity of Illness Index MH - Weight Gain/drug effects MH - Young Adult EDAT- 2014/03/04 06:00 MHDA- 2015/04/08 06:00 CRDT- 2014/03/04 06:00 PHST- 2014/03/04 06:00 [entrez] PHST- 2014/03/04 06:00 [pubmed] PHST- 2015/04/08 06:00 [medline] AID - 10.1097/YIC.0000000000000030 [doi] PST - ppublish SO - Int Clin Psychopharmacol. 2014 Sep;29(5):279-87. doi: 10.1097/YIC.0000000000000030.