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

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

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.

Intervention(s) in this Clinical Trial

• Drug: Paliperidone ER
  • 3mg to 12mg of Paliperidone ER once a day
• Drug: Risperidone
  • 1 to 6 mg of risperidone once or twice a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1. Paliperidone ER
  • New antipsychotics
• Active Comparator: 2 Risperidone

Primary Measures

• Neurocognitive function
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Positive and Negative Syndrome Scale (PANSS)
  • Time Frame: monthly
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 59 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Chonnam National University Hospital Other

Overall Clinical Trial Officials and Contacts

Jin-Sang Yoon, Professor Principal Investigator Dept. of Psychiatry, Chonnam National University Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00827840

Study ID Number: PAL-KOR-9006

ClinicalTrials.gov Identifier: NCT00827840

Health Authority: Korea: Food and Drug Administration