NCT01157351

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	paliperidone	flexible dosing as prescribed by the study doctor for 15 months
DRUG	risperidone	flexible dosing as prescribed by the study doctor for 15 months
DRUG	haloperidole	flexible dosing as prescribed by the study doctor for 15 months
DRUG	perphenazine	flexible dosing as prescribed by the study doctor for 15 months
DRUG	aripiprazole	flexible dosing as prescribed by the study doctor for 15 months
DRUG	quetiapine	flexible dosing as prescribed by the study doctor for 15 months
DRUG	paliperidone palmitate	78, 117, 156, or 234 mg monthly injection for 15 months
DRUG	olanzapine	flexible dosing as prescribed by the study doctor for 15 months

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-07-07
• Last updated: 2015-04-24
• Results posted: 2014-12-04

Locations

56 sites across 2 countries: United States, Puerto Rico