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

Chonnam National University

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Risperidone

Drug: Paliperidone ER

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00827840

PAL-KOR-9006

Details and patient eligibility

About

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

Full 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.

Enrollment

58 patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

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