J Korean Neuropsychiatr Assoc.  2001 Jul;40(4):693-707.

Efficacy and Safety of Olanzapine in the Treatment of Korean Patients with Schizophrenia and Schizophreniform Disorder: Open Multicenter Clinical Trial

• Ahn YM
• Kang DY
• Kwon JS
• Kim CY
• Kim CE
• Bahn G
• Shin Y
• Lee GC
• Lee DW
• Yi JS
• Cho HS
• Chae JH
• Kim YS

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.

Keyword

Olanzapine; Schizophrenia; Schizophreniform disorder; Efficacy; Safety; Multicenter clinical trial

MeSH Terms

Antipsychotic Agents
Depression
Dyskinesias
Hospitals, University
Humans
Hyperprolactinemia
Incidence
Movement Disorders
Plasma
Prolactin
Psychotic Disorders*
Schizophrenia*
Vital Signs
Weight Gain
Antipsychotic Agents
Prolactin