At a glance
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A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated
In Brief
A Phase 4 clinical trial evaluating paliperidone, risperidone, and 6 other interventions for Schizophrenia. Completed, enrolled 450 participants across 56 sites in 2 countries.
Detailed Summary
The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.
Study Details
Timeline
Interventions
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
78, 117, 156, or 234 mg monthly injection for 15 months
flexible dosing as prescribed by the study doctor for 15 months