NCT01193166

Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ortho-McNeil 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 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	paliperidone palmitate	78, 117, 156, or 234 mg monthly injection for 12 months
DRUG	risperidone	flexible dosing as prescribed by the study doctor for 12 months
DRUG	olanzapine	flexible dosing as prescribed by the study doctor for 12 months
DRUG	aripiprazole	flexible dosing as prescribed by the study doctor for 12 months
DRUG	haloperidole	flexible dosing as prescribed by the study doctor for 12 months
DRUG	quetiapine	flexible dosing as prescribed by the study doctor for 12 months
DRUG	perphenazine	flexible dosing as prescribed by the study doctor for 12 months
DRUG	paliperidone	flexible dosing as prescribed by the study doctor for 12 months

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-09-01
• Last updated: 2013-07-08