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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 version

Change 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

Page last updated: August 23, 2015

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