Schizophrenia | 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
Schizophrenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Paliperidone extended-releasePatients will receive 6 mg to 12 mg of paliperidone extended-release tablet once daily orally.
Drug:Risperidone immediate-releasePatients will receive 3 mg to 7 mg of risperidone immediate-release tablet orally.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2013
Completed Date: June 2015
Phase: Phase 4
Primary Outcome: Change in category fluency score of cognitive function scale (Cognitive Abilities Screening Instrument, Chinese version [CASI C-2.0]) from baseline to Week 24
Secondary Outcome: Change from baseline to Week 24 in score of Modified Wisconsin Card Sorting Test (MWCST) short version
Study sponsors, principal investigator, and references