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

Chonnam National University Hospital58 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Paliperidone ERDRUG

3mg to 12mg of Paliperidone ER once a day

RisperidoneDRUG

1 to 6 mg of risperidone once or twice a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Psychiatry, Chonnam National Univeristy Hospital

Gwangju, South Korea

Outcomes

Primary Outcomes

Neurocognitive function

Time frame: 12 weeks

Secondary Outcomes

Positive and Negative Syndrome Scale (PANSS)

Time frame: monthly

Data from ClinicalTrials.gov

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