A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

简要总结

主要结局

次要结局

• Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks(Baseline, 104 weeks)
• Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores(Baseline, 104 weeks)
• Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks(Baseline, 104 weeks)
• Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks(Baseline, 104 weeks)
• Resource Utilization: Number of Outpatient Physician Visits During the Study(Baseline through 104 weeks)
• Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study(Baseline through 104 weeks)
• Number of Hospitalization Days(Baseline through 104 weeks)
• Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks(Baseline, 104 weeks)
• Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks(Baseline, 104 weeks)
• Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks(Baseline, 104 weeks)
• Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks(Baseline, 104 weeks)
• Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items)(104 weeks)
• Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks(104 weeks)
• Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)(Baseline through 104 weeks)
• Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks(Baseline, 104 weeks)
• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks(Baseline, 104 weeks)
• Median Time to Relapse(Baseline to time of relapse (up to 104 weeks))
• Number of Participants Experiencing Relapse(Baseline through 104 weeks)
• Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks(Baseline, 104 weeks)
• Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization(Baseline through 104 Weeks)
• Change From Baseline in Weight at 104 Weeks(Baseline, 104 weeks)
• Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides(Baseline through 104 weeks)
• Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks(Baseline, 104 weeks)
• Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin(Baseline through 104 Weeks)
• Participants Discontinuing Because of an Adverse Event (AE) or Death(Baseline through 104 weeks)