Efficacy and Safety of Olanzapine in the Treatment of Korean Patients with Schizophrenia and Schizophreniform Disorder: Open Multicenter Clinical Trial.
- Author:
Yong Min AHN
1
;
Dae Yeob KANG
;
Jun Soo KWON
;
Chang Yoon KIM
;
Chul Eung KIM
;
Geonho BAHN
;
Youngmin SHIN
;
Gi Chul LEE
;
Dong Woo LEE
;
Jung Seo YI
;
Hyun Sang CHO
;
Jeong Ho CHAE
;
Yong Sik KIM
Author Information
1. Department of Psychiatry, Eulji University School of Medicine, Seoul.
- Publication Type:Clinical Trial ; Multicenter Study ; Original Article
- Keywords:
Olanzapine;
Schizophrenia;
Schizophreniform disorder;
Efficacy;
Safety;
Multicenter clinical trial
- MeSH:
Antipsychotic Agents;
Depression;
Dyskinesias;
Hospitals, University;
Humans;
Hyperprolactinemia;
Incidence;
Movement Disorders;
Plasma;
Prolactin;
Psychotic Disorders*;
Schizophrenia*;
Vital Signs;
Weight Gain
- From:Journal of Korean Neuropsychiatric Association
2001;40(4):693-707
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
OBJECTIVE: This multicenter clinical trial was carried out to investigate the efficacy and the safety of olanzapine for the treatment of Korean patients. METHOD: 105 patients with schizophrenia and schizophreniform disorder, visited at 10 mental or university hospitals, had received an open and non-comparative treatment with olanzapine for 8 weeks. Patients had psychotic or depressive symptoms with the severity above moderate degree or intolerable side effects to previous antipsychotics. After a wash-out period of 2-7 days, 10mg olanzapine was prescribed initially to all the patients, and then the dosage could be adjusted within the range of 5-20mg/day of olanzapine by 3-7 days. RESULTS: 90(85.7%) of 105 patients completed the 8-weeks trial and the mean modal dose of olanzapine was 16.1(+/-4.7)mg/day. At the end of the trial, 73 patients(69.5%) were classified as responder, which was defined as 40% or more improvement in BPRS(Brief Psychiatric Rating Scale) score comparing to baseline. There was a significant reduction in the scores of PANSS(Positive and Negative Syndrome Scale) and subscales including negative symptom scores and CGI. Also weekly analysis showed that the reductions in scores were kept on for the whole period of the trial. 43.8% of all the patients had depressive symptoms at the baseline and total scores of MADRS(Montgomery-sberg Depression Rating Scale) and HAM-A(Hamilton Rating Scale for Anxiety) were also reduced after the trials. Vital signs revealed no clinically significant changes but continuous weight gain was observed during the treatment with olanzapine. The scores of SAS(Simpson-Angus Scale) and AIMS(Abnormal Involuntary Movement Scale) for assessing the EPS(extrapyramidal symptoms) and tardive dyskinesia respectively were significantly decreased and only a few patients reported EPS as adverse events. Although mild and clinically non-significant elevation of ALT/SGPT was observed, most laboratory parameters including plasma prolactin level showed no significant changes during the trial. CONCLUSIONS: Although this trial had many limitations because it was a non-comparative and open study, olanzapine showed high efficacy on the positive, negative and depressive symptoms in schizophrenia and schizophreniform disorder. In addition to that, olanzapine showed a substantially favorable safety profile, such as low incidence of EPS and hyperprolactinemia.
