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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chonnam National University Hospital
• Collaborators: Janssen Korea, Ltd., Korea; Ministry of Health, Republic of Korea
• Treatments: Paliperidone Palmitate; Risperidone

Criteria

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