A Study to Evaluate the Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Cognitive Function in Clinically Stable Patients With Schizophrenia

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect of oral paliperidone extended-release and oral risperidone immediate-release on cognitive function, especially the category fluency of Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an established diagnosis of schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Taiwan Ltd
• Treatments: Paliperidone Palmitate; Risperidone

Criteria

Inclusion Criteria:

• Diagnosed with schizophrenia

• Cognitive abilities screening instrument C-2.0 total score between 50 and 85 (inclusive) at baseline

• Baseline positive and negative syndrome scale score between 60 and 85 (inclusive)

• Clinical global impression-severity change less than or equal to 1 in the month prior to randomization

• Patients on a stable therapeutic dose of oral risperidone IR (between 3-6 mg/day) for at least 4 weeks prior to randomization

Exclusion Criteria:

• Treatment refractory patients, defined as failure of more than or equal to 2 adequate trials of second generation antipsychotic treatment for schizophrenia

• History of neuroleptic malignant syndrome

• Allergy or hypersensitivity to risperidone or paliperidone, or to any of the excipients of oral risperidone IR or paliperidone ER tablets

• Participants who have taken paliperidone ER in the past

• Participants who have been treated with clozapine or any long-acting injectable (depot) antipsychotic within 3 months before randomization