Schizophrenia
Conditions
Brief summary
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
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.
Interventions
DRUGPaliperidone ER
3mg to 12mg of Paliperidone ER once a day
DRUGRisperidone
1 to 6 mg of risperidone once or twice a day
Sponsors
Janssen Korea, Ltd., Korea
Ministry of Health, Republic of Korea
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurocognitive function | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) | monthly |
Countries
South Korea
Outcome results
None listed