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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Johnson & Johnson Taiwan Ltd
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT01670071
First received: August 17, 2012
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone extended-release
Drug: Risperidone immediate-release
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • Change in category fluency score of cognitive function scale (Cognitive Abilities Screening Instrument, Chinese version [CASI C-2.0]) from baseline to Week 24 [ Time Frame: Baseline (Week 0), Week 4, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    CASI C-2.0 will be used to measure patient's cognitive ability. The range of CASI score is 0 to 100 (a higher score indicating better performance and is influenced by patient's educational level). The CASI C-2.0 provides quantitative assessment on 9 cognitive domains and 20 questions, including attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, category fluency, abstraction, and judgment.


Secondary Outcome Measures:
  • Change from baseline to Week 24 in score of Modified Wisconsin Card Sorting Test (MWCST) short version [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    The WCST was developed to assess abstract reasoning and ability to shift cognitive strategies in response to environmental changes. The materials consist of a pack of 4 stimulus cards and 48 response cards which are devised so that each card contains from 1 to 4 identical figures of a single color. Individually administered, it requires the patient to sort the cards according to different principles (ie, by color, form, or number). As the test progresses, there are unannounced shifts in the sorting principle which require the patient to alter his or her approach.

  • Change from baseline in score of Continuous Performance Test (CPT) [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    CPT is an attention test. Response patterns on the CPT II is used as an aid in monitoring treatment effectiveness. For example, some response patterns suggest inattentiveness or impulsivity, while other response patterns may indicate activation/arousal problems or difficulties maintaining vigilance.

  • Change from baseline in score of Personal and Social Performance (PSP) scale [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    The PSP is a clinician-rated instrument providing an overall rating of personal and social functioning in subjects with schizophrenia on a scale of 1-100. Four domains of functioning are considered in the rating: 1) socially useful activities, including work and study, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior.

  • Change from baseline in score of Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    The PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. The neuropsychiatric symptoms of schizophrenia will be assessed using the 30-item PANSS scale, which provides a total score (sum of the scores of all 30 items). Each scale is rated 1 (absent) to 7 (extreme).

  • Change from baseline in score of Clinical Global Impression-severity (CGI-S) scale [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given time.

  • Change from baseline in score of Medication Satisfaction Questionnaire (MSQ) [ Time Frame: Baseline, Week 4, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    MSQ is designed to assess treatment satisfaction among patients with schizophrenia. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone extended-release Drug: Paliperidone extended-release
Patients will receive 6 mg to 12 mg of paliperidone extended-release tablet once daily orally.
Other Name: Paliperidone
Active Comparator: Risperidone immediate-release Drug: Risperidone immediate-release
Patients will receive 3 mg to 7 mg of risperidone immediate-release tablet orally.
Other Name: Risperidone IR

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with schizophrenia
  • Cognitive abilities screening instrument C-2.0 total score between 60 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
  • Taken clozapine or paliperidone ER in the past, or have been treated with any long-acting injectable (depot) within 3 months before randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670071

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
Taiwan
Recruiting
Bali Township, Taipei County, Taiwan
Recruiting
Hua Lian, Taiwan
Recruiting
Kaohsiung, Taiwan
Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan Ltd Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT01670071     History of Changes
Other Study ID Numbers: CR100817, R076477SCH4066
Study First Received: August 17, 2012
Last Updated: November 14, 2014
Health Authority: Taiwan: Taiwan Food and Drug Administration
Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:
Schizophrenia
Paliperidone
Risperidone
Paliperidone extended-release (ER)
Risperidone immediate-release (IR)

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014