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

This study has been completed.
Sponsor:
Collaborators:
Janssen Korea, Ltd., Korea
Ministry of Health, Republic of Korea
Information provided by (Responsible Party):
Jin-Sang Yoon, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT00827840
First received: January 22, 2009
Last updated: December 22, 2011
Last verified: December 2011

January 22, 2009
December 22, 2011
November 2008
February 2011   (final data collection date for primary outcome measure)
Neurocognitive function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00827840 on ClinicalTrials.gov Archive Site
Positive and Negative Syndrome Scale (PANSS) [ Time Frame: monthly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • Drug: Paliperidone ER
    3mg to 12mg of Paliperidone ER once a day
    Other Name: Invega
  • Drug: Risperidone
    1 to 6 mg of risperidone once or twice a day
    Other Name: Risperdal
  • Experimental: 1. Paliperidone ER
    New antipsychotics
    Intervention: Drug: Paliperidone ER
  • Active Comparator: 2 Risperidone
    Intervention: Drug: Risperidone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00827840
PAL-KOR-9006
Yes
Jin-Sang Yoon, Chonnam National University Hospital
Chonnam National University Hospital
  • Janssen Korea, Ltd., Korea
  • Ministry of Health, Republic of Korea
Principal Investigator: Jin-Sang Yoon, Professor Dept. of Psychiatry, Chonnam National University Hospital
Chonnam National University Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP