Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia

Study Overview
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Brief Summary
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Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia. Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone

Detailed Description
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This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The patients will be randomized to the risperidone-continuation group in which they continue to receive risperidone, or to the paliperidone-switch group in which they are switched from risperidone to paliperidone. In the paliperidone-switch group, risperidone will be tapered off during the first 4 weeks of the study, while paliperidone is titrated simultaneously. The doses of both drugs will be adjusted according to the clinical judgment of each research psychiatrist, within 6 mg/day of risperidone and 12 mg/day of paliperidone.

Official Title
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Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Paliperidone ER
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as schizophrenia by DSM-IV-TR criteria both in inpatients Patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment. Patients with ability to complete various questionnaires. Patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form Exclusion Criteria: Active psychotic symptoms, including severe behavioral disturbance Relevant history of or current presence of any significant or unstable medical disease A woman who is pregnant, breast-feeding or planning to become pregnant during the study period Patients with the history of serious allergy or multiple adverse drug reactions Patients with the history of taking paliperidone ER within 60 days Patients with history of taking clozapine within 60 days Patients who require the treatment of other medications influencing CNS, except permitted concomitant drugs in advance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Paliperidone ER<br>New antipsychotics | Drug: Paliperidone ER<br>* 3mg to 12mg of Paliperidone ER once a day<br>* Other names: Invega;|
| Active Comparator: 2 Risperidone<br> | Drug: Risperidone<br>* 1 to 6 mg of risperidone once or twice a day<br>* Other names: Risperdal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive function |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) |  | monthly |