Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paliperidone ER
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- Dept. of Psychiatry, Chonnam National Univeristy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1. Paliperidone ER
2 Risperidone
Arm Description
New antipsychotics
Outcomes
Primary Outcome Measures
Neurocognitive function
Secondary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Full Information
NCT ID
NCT00827840
First Posted
January 22, 2009
Last Updated
December 22, 2011
Sponsor
Chonnam National University Hospital
Collaborators
Janssen Korea, Ltd., Korea, Ministry of Health, Republic of Korea
1. Study Identification
Unique Protocol Identification Number
NCT00827840
Brief Title
Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
Official Title
Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Janssen Korea, Ltd., Korea, Ministry of Health, Republic of Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Paliperidone ER
Arm Type
Experimental
Arm Description
New antipsychotics
Arm Title
2 Risperidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paliperidone ER
Other Intervention Name(s)
Invega
Intervention Description
3mg to 12mg of Paliperidone ER once a day
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
1 to 6 mg of risperidone once or twice a day
Primary Outcome Measure Information:
Title
Neurocognitive function
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Sang Yoon, Professor
Organizational Affiliation
Dept. of Psychiatry, Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Psychiatry, Chonnam National Univeristy Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22809972
Citation
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.
Results Reference
derived
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Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
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