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

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Paliperidone ER; Drug: Risperidone

• Registration Number: NCT00827840
• Lead Sponsor: Chonnam National University Hospital

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-22
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Paliperidone ER	Paliperidone ER	New antipsychotics
2 Risperidone	Risperidone	-

Primary Outcome Measures

Name	Time	Method
Neurocognitive function	12 weeks

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	monthly

Trial Locations

Locations (1)

Dept. of Psychiatry, Chonnam National Univeristy Hospital; 🇰🇷 Gwangju, Korea, Republic of