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

Information source: Chonnam National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Paliperidone ER (Drug); Risperidone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Chonnam National University Hospital

Official(s) and/or principal investigator(s):
Jin-Sang Yoon, Professor, Principal Investigator, Affiliation: Dept. of Psychiatry, Chonnam National University Hospital

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Neurocognitive function

Secondary outcome: Positive and Negative Syndrome Scale (PANSS)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 59 Years. Gender(s): Both.

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

Locations and Contacts

Dept. of Psychiatry, Chonnam National Univeristy Hospital, Gwangju 501-757, Korea, Republic of
Additional Information

Starting date: November 2008
Last updated: December 22, 2011

Page last updated: August 23, 2015

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