Clinical trial NCT01157351
Conditions: Schizophrenia
Keywords: Schizophrenia Risperidone Risperdal Paliperidone palmitate Aripiprazole Haloperidol Olanzapine Paliperidone Perphenazine Quetiapine
Sponsor: Janssen Scientific Affairs, LLC
Start date: 2010-05-01; Completion date: 2013-12-01
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
The primary objective of this study is to compare the efficacy of paliperidone palmitate 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. Protocol-defined treatment failure is defined as arrest, psychiatric hospitalization, increase in psychiatric services to prevent imminent hospitalization, discontinuation of antipsychotic treatment due to inadequate efficacy, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to safety or tolerability or completed suicide. Protocol was amended on March 15, 2011 to reflect changes in the inclusion/exclusion criteria as well as the study objectives. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for fifteen months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.

Arms: arm 1: paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months arm 2: aripiprazole flexible dosing as prescribed by the study doctor for 15 months arm 3: haloperidole flexible dosing as prescribed by the study doctor for 15 months arm 4: olanzapine flexible dosing as prescribed by the study doctor for 15 months arm 5: paliperidone flexible dosing as prescribed by the study doctor for 15 months arm 6: perphenazine flexible dosing as prescribed by the study doctor for 15 months arm 7: quetiapine flexible dosing as prescribed by the study doctor for 15 months arm 8: risperidone flexible dosing as prescribed by the study doctor for 15 months
Interventions: intervention 1: paliperidone intervention 2: risperidone intervention 3: haloperidole intervention 4: perphenazine intervention 5: aripiprazole intervention 6: quetiapine intervention 7: paliperidone palmitate intervention 8: olanzapine
Intervention descriptions: intervention 1: flexible dosing as prescribed by the study doctor for 15 months intervention 2: flexible dosing as prescribed by the study doctor for 15 months intervention 3: flexible dosing as prescribed by the study doctor for 15 months intervention 4: flexible dosing as prescribed by the study doctor for 15 months intervention 5: flexible dosing as prescribed by the study doctor for 15 months intervention 6: flexible dosing as prescribed by the study doctor for 15 months intervention 7: 78, 117, 156, or 234 mg monthly injection for 15 months intervention 8: flexible dosing as prescribed by the study doctor for 15 months

Protocol documents: