The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.
The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
78, 117, 156, or 234 mg monthly injection for 12 months
flexible dosing as prescribed by the study doctor for 12 months
flexible dosing as prescribed by the study doctor for 12 months
Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services
Time frame: Up to 12 months
Change in Clinical Global Impression-Severity score
Time frame: Up to 12 months
Change in Global Assessment of Functionality score
Time frame: Up to 12 months
Change in Medication Satisfaction Questionnaire score
Time frame: Up to 12 months
Proportion of subjects with at least one psychiatric hospitalization
Time frame: Up to 12 months
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flexible dosing as prescribed by the study doctor for 12 months
flexible dosing as prescribed by the study doctor for 12 months
flexible dosing as prescribed by the study doctor for 12 months
flexible dosing as prescribed by the study doctor for 12 months
flexible dosing as prescribed by the study doctor for 12 months