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

NCT ID: NCT00827840

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Paliperidone ER

New antipsychotics

Group Type EXPERIMENTAL

Paliperidone ER

Intervention Type DRUG

3mg to 12mg of Paliperidone ER once a day

2 Risperidone

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

1 to 6 mg of risperidone once or twice a day

Interventions

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Paliperidone ER

3mg to 12mg of Paliperidone ER once a day

Intervention Type DRUG

Risperidone

1 to 6 mg of risperidone once or twice a day

Intervention Type DRUG

Other Intervention Names

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Invega Risperdal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role collaborator

Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Sang Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Sang Yoon, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of Psychiatry, Chonnam National University Hospital

Locations

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Dept. of Psychiatry, Chonnam National Univeristy Hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

References

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Kim SW, Chung YC, Lee YH, Lee JH, Kim SY, Bae KY, Kim JM, Shin IS, Yoon JS. Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial. Int Clin Psychopharmacol. 2012 Sep;27(5):267-74. doi: 10.1097/YIC.0b013e328356acad.

Reference Type DERIVED
PMID: 22809972 (View on PubMed)

Other Identifiers

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PAL-KOR-9006

Identifier Type: -

Identifier Source: org_study_id