Clinical trial NCT01670071: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone
Risperidone
Paliperidone extended-release (ER)
Risperidone immediate-release (IR)
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in category fluency score of cognitive function scale (Cognitive Abilities Screening Instrument, Chinese version [CASI C-2.0]) from baseline to Week 24
timeFrame: Baseline (Week 0), Week 4, Week 12 and Week 24
Secondary outcomes:
measure: Change from baseline to Week 24 in score of Modified Wisconsin Card Sorting Test (MWCST) short version
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Change from baseline in score of Continuous Performance Test (CPT)
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Change from baseline in score of Personal and Social Performance (PSP) scale
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Change from baseline in score of Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Change from baseline in score of Clinical Global Impression-severity (CGI-S) scale
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Change from baseline in score of Medication Satisfaction Questionnaire (MSQ)
timeFrame: Baseline, Week 4, Week 12 and Week 24
Other outcomes:
Locations:
city: Bali Township, Taipei County
country: Taiwan
city: Hua Lian
country: Taiwan
city: Kaohsiung
country: Taiwan
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan Ltd Clinical Trial
role: STUDY_DIRECTOR
References: