Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia

简要总结

主要结局

次要结局

• The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S);
• The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive);
• The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS);
• The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of
• the PANSS_EC from baseline;
• The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment
• of Nursing Intervention
• The proportion of patients using pm lorazepam and the time-course of usage.
• The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening
• of psychiatric illness.
• Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10).
• A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the
• primary objective respectively.
• Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5
• days in the treatment of acutely ill patients with schizophrenia as assessed by:
• Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES);
• Review of spontaneous (unsolicited) treatment emergent adverse events;
• Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores.