ABSTRACT
OBJECTIVE: This multicenter, open trial with olanzapine was primarily designed to evaluate effects of olanzapine on profiles of efficacy, safety, and subjective quality of life (QoL) in hospitalized patients with schizophrenia or other psychotic disorders. Secondarily, associations of changes in QoL measures with baseline characteristics and changes in efficacy and safety measures were examined. Finally, the optimal dose of olanzapine was investigated with respect to efficacy, safety and QoL profiles. METHODS: A total of 94 inpatients at nine centers in Chungchung and Honam areas of Korea was recruited. The administered dosage of olazapine varied between 5 to 20 mg/day according to each patient's clinical status. Information on socio-demographic and clinical characteristics was collected. A variety of measures on efficacy, safety and QoL was administered at baseline (admission) and at endpoint (discharge). RESULTS: Seventy-three (78%) patients completed the study. Their mean (SD) admission period was 42 (21) days. Olanzapine was effective for reducing overall psychotic symptoms including negative and depressive symptoms. It was safe and generally well tolerated, particularly in extrapyramidal symptoms, although weight gain was substantial (2.6 kg during admission period). Furthermore, it was beneficial for improving QoL. Changes in QoL measures were independently associated with improvement of nighttime sleep. The most favorable dosages of olanzapine were 17.5 or 20 mg/day in terms of efficacy, while were 7.5 or 10 mg/day with respect to safety and QoL. CONCLUSION: Olanzapine was effective and well tolerated in the treatment of inpatients with schizophrenia and other psychotic disorders. Different optimal dosages of olanzapine might be recommended according to the target or goal of treatments.
Subject(s)
Humans , Depression , Inpatients , Korea , Psychotic Disorders , Quality of Life , Schizophrenia , Weight GainABSTRACT
OBJECTIVE: The aim of this study is to determine effects of nefazodone on depression, anxiety, sleep and sexual function in depressive patients. SUBJECTS AND METHODS: This is an open, non-comparative, multi-center study. Antidepressant and other clinical effects of nefazodone were evaluated in 230 patients of 26 centers, aged 14 years or more, who met DSM-IV criteria to major depressive disorder or dysthymic disorder and didn't have other psychiatric disorders and were physically healthy. The clinical efficacy was assessed at week 1, 2, 4 and 8 using Clinical Global Improvement (CGI), Hamilton Depression Scale (HAM-D), Beck Depression Inventory (BDI), State and Trait Anxiety Inventory-State Anxiety (STAI-SA). Other clinical effects were assessed with Weekly Sleep Questionnaire, Sexual Functioning Questionnaire and GHQ-QOL-12, a scale for quality of life. Adverse drug reactions were checked with a questionnaire. Post-treatment effects of drug were compared with pre-treatment baseline condition. RESULTS: The response rates by Clincal Grobal Improvement and HAM-D after 8 weeks treatment were 62.4% and 75.2% respectively. Comparing to baseline, nefazodone was proved to have significantly higher antidepressant and antianxiety effects in depressive patients and it improved also sleep, sexual functions and quality of life. Both patients and physicians satisfied with the effects of drug. Adverse drug reactions were a few and not serious, and most of them disappeared as treatment continued. CONCLUSION: These results suggest that not only nefazodone has antidepressant effects and antianxiety effects, but also it improves sleep disturbance, sexual dysfunction and the quality of life in depressive patients. Adverse drug reactions were a few and not serious.