<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01670071</url>
  </required_header>
  <id_info>
    <org_study_id>CR100817</org_study_id>
    <secondary_id>R076477SCH4066</secondary_id>
    <nct_id>NCT01670071</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Taiwan Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Taiwan Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effect of oral paliperidone extended-release and&#xD;
      oral risperidone immediate-release on cognitive function, especially the category fluency of&#xD;
      Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an&#xD;
      established diagnosis of schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 28-week, randomized (the study medication is assigned by chance), open-label (all&#xD;
      people know the identity of the intervention), active-controlled (patients are assigned to&#xD;
      either a recognized effective treatment or the study medication) comparative study. All&#xD;
      patients will enter a run-in period to receive a stable therapeutic dose of oral risperidone&#xD;
      immediate-release for at least 4 weeks. After the 4-week run-in period, patients will be&#xD;
      randomly assigned to either remain on oral risperidone immediate-release (IR) or to receive a&#xD;
      therapeutic dose of oral paliperidone extended-release (ER) and patients will be&#xD;
      prospectively followed for a 24-week treatment phase. The treatment phase is composed of a&#xD;
      4-week flexible dose period followed by a 20-week stable dose period. During the 4-week&#xD;
      flexible dose period, the dose of paliperidone ER or risperidone IR may be increased or&#xD;
      decreased for each patient if clinically indicated (eg, significant side effects emerge or&#xD;
      there is evidence of a lack of efficacy). At the end of 4-week flexible dose period, the&#xD;
      final dose should be maintained for the 20-week fixed-dose period. Efficacy and safety will&#xD;
      be assessed at baseline (Week 0) and Weeks 4, 12, and 24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated due to insufficient sample size and protocol compliance issue.&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <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</measure>
    <time_frame>Baseline (Week 0), Week 4, Week 12 and Week 24</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to Week 24 in score of Modified Wisconsin Card Sorting Test (MWCST) short version</measure>
    <time_frame>Baseline, Week 4, Week 12 and Week 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in score of Continuous Performance Test (CPT)</measure>
    <time_frame>Baseline, Week 4, Week 12 and Week 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in score of Personal and Social Performance (PSP) scale</measure>
    <time_frame>Baseline, Week 4, Week 12 and Week 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in score of Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>Baseline, Week 4, Week 12 and Week 24</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in score of Clinical Global Impression-severity (CGI-S) scale</measure>
    <time_frame>Baseline, Week 4, Week 12 and Week 24</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in score of Medication Satisfaction Questionnaire (MSQ)</measure>
    <time_frame>Baseline, Week 4, Week 12 and Week 24</time_frame>
    <description>MSQ is designed to assess treatment satisfaction among patients with schizophrenia. It consists of 1 question: &quot;Overall, how satisfied are you with your current antipsychotic medication(s)?&quot; 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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Paliperidone extended-release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Risperidone immediate-release</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paliperidone extended-release</intervention_name>
    <description>Patients will receive 6 mg to 12 mg of paliperidone extended-release tablet once daily orally.</description>
    <arm_group_label>Paliperidone extended-release</arm_group_label>
    <other_name>Paliperidone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone immediate-release</intervention_name>
    <description>Patients will receive 3 mg to 7 mg of risperidone immediate-release tablet orally.</description>
    <arm_group_label>Risperidone immediate-release</arm_group_label>
    <other_name>Risperidone IR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with schizophrenia&#xD;
&#xD;
          -  Cognitive abilities screening instrument C-2.0 total score between 50 and 85&#xD;
             (inclusive) at baseline&#xD;
&#xD;
          -  Baseline positive and negative syndrome scale score between 60 and 85 (inclusive)&#xD;
&#xD;
          -  Clinical global impression-severity change less than or equal to 1 in the month prior&#xD;
             to randomization&#xD;
&#xD;
          -  Patients on a stable therapeutic dose of oral risperidone IR (between 3-6 mg/day) for&#xD;
             at least 4 weeks prior to randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment refractory patients, defined as failure of more than or equal to 2 adequate&#xD;
             trials of second generation antipsychotic treatment for schizophrenia&#xD;
&#xD;
          -  History of neuroleptic malignant syndrome&#xD;
&#xD;
          -  Allergy or hypersensitivity to risperidone or paliperidone, or to any of the&#xD;
             excipients of oral risperidone IR or paliperidone ER tablets&#xD;
&#xD;
          -  Participants who have taken paliperidone ER in the past&#xD;
&#xD;
          -  Participants who have been treated with clozapine or any long-acting injectable&#xD;
             (depot) antipsychotic within 3 months before randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnson &amp; Johnson Taiwan Ltd Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johnson Taiwan Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Bali Township, Taipei County</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hua Lian</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&amp;studyid=3485&amp;filename=CR100817_CSR.pdf</url>
    <description>Paliperidone ER and oral risperidone - A 6-month prospective pilot RCT, exploring differential effects on cognitive domains in patients with schizophrenia</description>
  </link>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>April 12, 2016</last_update_submitted>
  <last_update_submitted_qc>April 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Paliperidone</keyword>
  <keyword>Risperidone</keyword>
  <keyword>Paliperidone extended-release (ER)</keyword>
  <keyword>Risperidone immediate-release (IR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Risperidone</mesh_term>
    <mesh_term>Paliperidone Palmitate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01670071
org study id: CR100817
secondary id: R076477SCH4066
nct id: NCT01670071
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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
time frame: Baseline (Week 0), Week 4, Week 12 and Week 24
description: 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.
measure: 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
description: 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.
measure: Change from baseline in score of Continuous Performance Test (CPT)
time frame: Baseline, Week 4, Week 12 and Week 24
description: 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.
measure: Change from baseline in score of Personal and Social Performance (PSP) scale
time frame: Baseline, Week 4, Week 12 and Week 24
description: 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.
measure: Change from baseline in score of Positive and Negative Syndrome Scale (PANSS)
time frame: Baseline, Week 4, Week 12 and Week 24
description: 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).
measure: Change from baseline in score of Clinical Global Impression-severity (CGI-S) scale
time frame: Baseline, Week 4, Week 12 and Week 24
description: 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.
measure: Change from baseline in score of Medication Satisfaction Questionnaire (MSQ)
time frame: Baseline, Week 4, Week 12 and Week 24
description: 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.
arm group label: Paliperidone extended-release
arm group type: Experimental
arm group label: Risperidone immediate-release
arm group type: Active Comparator
intervention type: Drug
intervention name: Paliperidone extended-release
description: Patients will receive 6 mg to 12 mg of paliperidone extended-release tablet once daily orally.
arm group label: Paliperidone extended-release
other name: Paliperidone
intervention type: Drug
intervention name: Risperidone immediate-release
description: Patients will receive 3 mg to 7 mg of risperidone immediate-release tablet orally.
arm group label: Risperidone immediate-release
other name: Risperidone IR
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Johnson & Johnson Taiwan Ltd Clinical Trial
role: Study Director
affiliation: Johnson & Johnson Taiwan Ltd
facility: 
facility: 
facility: 
country: Taiwan
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=3485&filename=CR100817_CSR.pdf
description: Paliperidone ER and oral risperidone - A 6-month prospective pilot RCT, exploring differential effects on cognitive domains in patients with schizophrenia
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Risperidone
mesh term: Paliperidone Palmitate