15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

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 Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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
Enrollment: 450
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: 001 (paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months)
- Experimental: 002 (aripiprazole flexible dosing as prescribed by the study doctor for 15 months)
- Experimental: 003 (haloperidole flexible dosing as prescribed by the study doctor for 15 months)
- Experimental: 004 (olanzapine flexible dosing as prescribed by the study doctor for 15 months)
- Experimental: 005 (paliperidone flexible dosing as prescribed by the study doctor for 15 months)
- Experimental: 006 (perphenazine flexible dosing as prescribed by the study doctor for 15 months)
- Experimental: 007 (quetiapine flexible dosing as prescribed by the study doctor for 15 months)
- Experimental: 008 (risperidone flexible dosing as prescribed by the study doctor for 15 months)


Related journal: Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study.