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

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Paliperidone extended-release

Drug: Risperidone immediate-release

Study type

Interventional

Funder types

Industry

Identifiers

NCT01670071

R076477SCH4066 (Other Identifier)

CR100817

Details and patient eligibility

About

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.

Full description

This is a 28-week, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), active-controlled (patients are assigned to either a recognized effective treatment or the study medication) comparative study. All patients will enter a run-in period to receive a stable therapeutic dose of oral risperidone immediate-release for at least 4 weeks. After the 4-week run-in period, patients will be randomly assigned to either remain on oral risperidone immediate-release (IR) or to receive a therapeutic dose of oral paliperidone extended-release (ER) and patients will be prospectively followed for a 24-week treatment phase. The treatment phase is composed of a 4-week flexible dose period followed by a 20-week stable dose period. During the 4-week flexible dose period, the dose of paliperidone ER or risperidone IR may be increased or decreased for each patient if clinically indicated (eg, significant side effects emerge or there is evidence of a lack of efficacy). At the end of 4-week flexible dose period, the final dose should be maintained for the 20-week fixed-dose period. Efficacy and safety will be assessed at baseline (Week 0) and Weeks 4, 12, and 24.

Enrollment

17 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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