A Study to Evaluate the Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Cognitive Function in Clinically Stable Patients With Schizophrenia
Information source: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Paliperidone extended-release (Drug); Risperidone immediate-release (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Johnson & Johnson Taiwan Ltd Official(s) and/or principal investigator(s): Johnson & Johnson Taiwan Ltd Clinical Trial, Study Director, Affiliation: Johnson & Johnson Taiwan Ltd
Summary
The purpose of this study is to compare the effect of oral paliperidone extended-release and
oral risperidone immediate-release on cognitive function, especially the category fluency of
Cognitive Abilities Screening Instrument, Chinese version (CASI C-2. 0), in patients with an
established diagnosis of schizophrenia.
Clinical Details
Official title: A Randomized, Open-Label, Study To Evaluate The Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Selected Cognitive Domains in Clinically Stable Subjects With Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in category fluency score of cognitive function scale (Cognitive Abilities Screening Instrument, Chinese version [CASI C-2.0]) from baseline to Week 24
Secondary outcome: Change from baseline to Week 24 in score of Modified Wisconsin Card Sorting Test (MWCST) short versionChange from baseline in score of Continuous Performance Test (CPT) Change from baseline in score of Personal and Social Performance (PSP) scale Change from baseline in score of Positive and Negative Syndrome Scale (PANSS) Change from baseline in score of Clinical Global Impression-severity (CGI-S) scale Change from baseline in score of Medication Satisfaction Questionnaire (MSQ)
Detailed description:
This is a 28-week, randomized (the study medication is assigned by chance), open-label (all
people know the identity of the intervention), active-controlled (patients are assigned to
either a recognized effective treatment or the study medication) comparative study. All
patients will enter a run-in period to receive a stable therapeutic dose of oral risperidone
immediate-release for at least 4 weeks. After the 4-week run-in period, patients will be
randomly assigned to either remain on oral risperidone immediate-release (IR) or to receive
a therapeutic dose of oral paliperidone extended-release (ER) and patients will be
prospectively followed for a 24-week treatment phase. The treatment phase is composed of a
4-week flexible dose period followed by a 20-week stable dose period. During the 4-week
flexible dose period, the dose of paliperidone ER or risperidone IR may be increased or
decreased for each patient if clinically indicated (eg, significant side effects emerge or
there is evidence of a lack of efficacy). At the end of 4-week flexible dose period, the
final dose should be maintained for the 20-week fixed-dose period. Efficacy and safety will
be assessed at baseline (Week 0) and Weeks 4, 12, and 24.
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with schizophrenia
- Cognitive abilities screening instrument C-2. 0 total score between 50 and 85
(inclusive) at baseline
- Baseline positive and negative syndrome scale score between 60 and 85 (inclusive)
- Clinical global impression-severity change less than or equal to 1 in the month prior
to randomization
- Patients on a stable therapeutic dose of oral risperidone IR (between 3-6 mg/day) for
at least 4 weeks prior to randomization
Exclusion Criteria:
- Treatment refractory patients, defined as failure of more than or equal to 2 adequate
trials of second generation antipsychotic treatment for schizophrenia
- History of neuroleptic malignant syndrome
- Allergy or hypersensitivity to risperidone or paliperidone, or to any of the
excipients of oral risperidone IR or paliperidone ER tablets
- Participants who have taken paliperidone ER in the past
- Participants who have been treated with clozapine or any long-acting injectable
(depot) antipsychotic within 3 months before randomization
Locations and Contacts
Bali Township, Taipei County, Taiwan
Hua Lian, Taiwan
Kaohsiung, Taiwan
Additional Information
Starting date: January 2013
Last updated: June 15, 2015
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