Psychiatric emergency multi-center randomized clinical trial on unanswered questions of pharmacotherapy in acute-phase schizophrenia
- Conditions
- schizophrenia, schizophreniform disorder, schizoafective disorder
- Registration Number
- JPRN-UMIN000005526
- Lead Sponsor
- Juntendo University Faculty of Medicine
- Brief Summary
Results: It was not conclusive about the primary outcome measure because the number of patients allocated to each treatment group was approximately 60% of the required number of patients set by power analysis. The Negative score of the Positive and Negative Syndrome Scale was significantly higher in high-dose patients than in conventional-dose patients. Serum olanzapine concentrations at the timing of oral 20 mg/day could be obtained from 5 out of 7 patients who subsequently required high-dose olanzapine. All values reached a therapeutic range of 20-50 ng/mL, and the mean value was 47.876 (SD 21.546) ng/mL. Conclusion: The present study has shown evidence that the reason for requiring high-dose olanzapine cannot be explained by pharmacokinetics for the first time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
1) severe liver, renal, heart, or respiratory dysfunction 2) diabetes mellitus, or its history 3) pregnant, nursing, or desiring to be pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method