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CompletedNCT00827840Updated Dec 23, 2011

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

A Phase 4 interventional study of Paliperidone ER and Risperidone in Schizophrenia, sponsored by Chonnam National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2011-12-23.

Sponsored by Chonnam National University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 58 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Chonnam National University Hospital is the lead sponsor of 70 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    1. Paliperidone ER

    New antipsychotics

    Drug: Paliperidone ER

  • Active comparator
    2 Risperidone

    Drug: Risperidone

Interventions

  • DrugPaliperidone ER

    3mg to 12mg of Paliperidone ER once a day

    Also known as: Invega

  • DrugRisperidone

    1 to 6 mg of risperidone once or twice a day

    Also known as: Risperdal

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What researchers measure

Primary outcomes

  1. Neurocognitive function

    Time frame: 12 weeks

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: monthly

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Study locations

1 site
  • Dept. of Psychiatry, Chonnam National Univeristy Hospital
    Gwangju, 501-757, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 22809972 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00827840
Lead sponsor
Chonnam National University Hospital
Collaborators
Janssen Korea, Ltd., Korea, Ministry of Health, Republic of Korea
Responsible party
Jin-Sang Yoon (Professor, Chonnam National University Hospital) — Principal investigator
First posted
Jan 23, 2009
Start date
Nov 2008
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Dec 23, 2011

Study contacts

Jin-Sang Yoon, Professor
principal investigator · Dept. of Psychiatry, Chonnam National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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