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

NCT01193166 ↗

Phase 4 Withdrawn Ortho-McNeil Janssen Scientific Affairs, LLC

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2010-08
Primary completion: 2012-09
Completion: 2012-09

Outcome

Outcome not reported

Stopped (Business): “This study was stopped due to an internal reconsideration of priorities of the product portfolio.”

Publications

Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aripiprazole	Other / unclassified	—	Oral
Comparator	Haloperidol	Other / unclassified	—	Oral
Comparator	Olanzapine	Small molecule	—	Oral
Subject	Paliperidone	Unknown	—	Oral
Comparator	Perphenazine	Small molecule	—	Oral
Comparator	Quetiapine	Small molecule	—	Oral
Comparator	Risperidone	Other / unclassified	—	Oral
Subject	paliperidone palmitate	Unknown	78 mg	Other
Subject	paliperidone palmitate	Unknown	117 mg	Other
Subject	paliperidone palmitate	Unknown	156 mg	Other
Subject	paliperidone palmitate	Unknown	234 mg	Other