ABSTRACT
OBJECTIVES: This randomized, multicenter, open-label, parallel clinical trial was carried to compare the therapeutic efficacy and the proportion of successful switch between 'direct switching method' and 'start-tapering switching method' when switching an antipsychotic to olanzapine. METHODS: This study included both inpatients and outpatients who fulfilled the criteria for schizophrenia as defined in the ICD-10 from 13 hospitals, and were in need to be appropriate for switching antipsychotics. Subjects were randomly assigned to one of the two switching methods. For 'direct switching method' group, previous antipsychotics were abruptly discontinued and 10mg of olanzapine was administered, whereas for 'start-tapering switching method' group, initially 10mg of olanzapine was administered and previous antipsychotics was gradually tapered for 2 weeks. Olanzapine was used for 6 weeks and the dose was adjusted within the range of 5-20mg. The therapeutic efficacy was measured with PANSS, BPRS, and CGI-Severity. A successful switching was defined as the completion of the 6 week trial without either worsening of the symptom(i.e. CGI-S score becomes worse twice consecutively) or the exacerbation of extrapyramidal symptoms(i.e. Simpson-Angus Scale scores becomes worse). RESULTS: 103 schizophrenic patients were participated in this study. There were no differences in baseline characteristics such as the demographic variables, the severity of symptoms, the history of previous antipsychotics treatments, the dosage of olanzapine used and the compliance between two groups. The proportion of successful switch was 71.1% for "direct switching method" and 82.2% for "start-tapering switching method", and there was no significant difference between the two switching methods. Also response rates to olanzapine based on total PANSS total scores were not different between the two groups(26.9% vs. 31.1%). At the time of completion of the trial, the scores of PANSS total, PANSS subscales, CGI-S and BPRS have significantly decreased after switching to olanzapine. But the changes of all scales measuring therapeutic efficacy in both endpoint and weekly analyses were not significantly different between the two switching methods. CONCLUSION: Although this study trial has many limitations and problems as an open clinical trial, the results may suggest that there were no significant differences between the two switching methods in the therapeutic efficacy. It was also found that the additional therapeutic benefits could be obtained by switching their antipsychotics to olanzapine.
Subject(s)
Humans , Antipsychotic Agents , Compliance , Inpatients , International Classification of Diseases , Outpatients , Schizophrenia , Weights and MeasuresABSTRACT
OBJECTIVES: This multicenter clinical trial involving 13 hospital sites compared the safety of switching to olanzapine between 'direct switching method' and 'start-tapering switching method'. METHOD: This study included both inpatients and outpatients who fulfilled the criteria for schizophrenia as defined in the ICD-10, and were in need to be appropriate for switching antipsychotics. Subjects were randomly assigned to one of the two switching methods. For 'direct switching method' group, previous antipsychotics were abruptly discontinued and 10mg of olanzapine was administered, whereas for 'start-tapering switching method' group, initially 10mg of olanzapine was administered and previous antipsychotics was gradually tapered for 2 weeks. Olanzapine was used for 6 weeks and the dose was adjusted within the range of 5-20mg. The safety of switching to olanzapine was measured with vital signs including body weight, adverse events reported spontaneously, laboratory tests, and various scales such as Simpson-Angus Scale(SAS), Barnes Akathisia Rating Scale(BARS), Abnormal Involuntary Movement Scale(AIMS), and Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS). RESULTS: 103 patients were switched to olanzapine in this study. The comparison between two switching methods did not show any significant difference in the dosage of olanzapine used, the concomitant use of benzodiazepine, the rate and reasons of drop-out, the adverse events, vital signs, laboratory tests, and most scales for measuring side-effects. However, the decrease in AIMS scores was significantly lower in 'direct switching method' group, and the concomitant use of anticholinergics was comparatively greater in 'start-tapering switching method' group. At baseline, SAS and BARS scores were 3.5 and 1.8 points respectively, and more than 70% of the subjects showed hyperprolactinemia. After switching to olanzapine, SAS, BARS, and AIMS scores were significantly decreased and the proportion of the patients with hyperprolactinemia was also decreased to less than 30%. However significant weight gain after the treatment of olanzapine was observed regardless of switching method. CONCLUSION: This study may suggest that switching to olanzapine can be done with relatively high safety regardless of switching methods and olanzapine can significantly decrease some side-effects induced by other antipsychotics.
Subject(s)
Humans , Antipsychotic Agents , Benzodiazepines , Body Weight , Cholinergic Antagonists , Dyskinesias , Hyperprolactinemia , Inpatients , International Classification of Diseases , Outpatients , Psychomotor Agitation , Schizophrenia , Vital Signs , Weight Gain , Weights and MeasuresABSTRACT
OBJECTIVES: This study aimed to provide a basic data of female alcoholics by understanding the gender differences of the clinical characteristics including demographic characteristics, alcoholic history, family history, drinking patterns, reasons for drinking, and comorbidity in male and female alcoholics. It also ained to establish the therapeutic plans through understanding the patterns of disease and the patterns of family cooperation in female alcoholics. METHODS: The study subjects consisted of 51 male and female alcoholics admitted to a mental hospital from January 1, 1991 to May 31, 1996. Subjects were age- and sex-matched. We reviewed patients' charts and administered questionaires. Mean age of female alcoholics was 44.45+/-11.02 years and that of male alcoholics was 44.17+/-10.08 years. All male and female patients met with the DSM-III-R criteria of alcohol dependence. RESULTS: Female alcoholics were later in drinking-onset age, and to had shorter duration of previous drinking history and less average amount of daily drinking than male alcoholics. And female alcoholics were found to seek treatment more voluntarily, and to have less frequent delirium tremens after admission and less medical complications such as hepatitis and diabetes mellitus. Also female alcoholics had more frustration experiences of separation such as death of family member, divorce, and husband's physical abuse. Female alcoholic's families had more uncooperative attitude toward treatment such as threat to divorce after admission. CONCLUSIONS: There were many differences between male and female alcoholics of demographic characteristics, clinical characteristics, and patterns of family cooperation. Female alcoholics were found to have more experiences of psychosocial frustration including death of family member and marital conflicts, and more uncooperative attitude of her family members. Therefore, it is required that therapists consider the characteristics of female alcoholics upon treatment and prevention, and have more concern about female alcoholics.