<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/NCT01682161</url>
  </required_header>
  <id_info>
    <org_study_id>CR100740</org_study_id>
    <secondary_id>R092670SCH4010</secondary_id>
    <secondary_id>PALM-KOR-4001</secondary_id>
    <nct_id>NCT01682161</nct_id>
  </id_info>
  <brief_title>A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate</brief_title>
  <official_title>An Open-Label, Comparative Study of Immediate or Delayed Switch to Paliperidone Palmitate in Patients Unsatisfied With Current Oral Atypical Antipsychotics to Evaluate the Evolution of Medication Satisfaction and Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Korea, Ltd., Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Korea, Ltd., Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the change of medication satisfaction measured by&#xD;
      Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are&#xD;
      switched into paliperidone palmitate, either immediately or in a delayed mode.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective (patients are first identified and then followed forward as time&#xD;
      passes), multicenter (study conducted at multiple sites), randomized (the study medication is&#xD;
      assigned by chance), comparative and open-labeled (all people know the identity of the&#xD;
      intervention) study.&#xD;
&#xD;
      The study mainly consists of 3 phases including, the screening phase (14 days before&#xD;
      administration of study medication), treatment phase, and the follow-up phase (28 days after&#xD;
      the last dose of the study medication). In the treatment phase, patients will be randomly&#xD;
      assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown&#xD;
      characteristics. Group 1 (immediate switch group): Patients will be administered with&#xD;
      paliperidone palmitate immediately after randomization and will continue throughout the&#xD;
      treatment phase. Group 2 (delayed switch group): Patients will remain on current oral&#xD;
      antipsychotics until Week 8, and later on will be completely switched to paliperidone&#xD;
      palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further&#xD;
      deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.&#xD;
&#xD;
      Safety evaluations will include evaluation of adverse events, clinical laboratory tests,&#xD;
      electrocardiogram, vital signs, and physical examination and these will be monitored&#xD;
      throughout the study.&#xD;
&#xD;
      The total duration of the study will be approximately 148 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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 from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)</measure>
    <time_frame>Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21</time_frame>
    <description>MSQ is designed to assess treatment satisfaction among patients with schizophrenia. The responses will be assessed on a 7-point Likert-type 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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)</measure>
    <time_frame>Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21</time_frame>
    <description>The TSQM is a 14-item subject assessed evaluation of treatment medication using a 7-point Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7= Extremely Satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>Baseline, Week 8, and Week 21</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. Each item is rated as follows: 1=absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate Severe, 6=Severe, and 7=Extreme.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale</measure>
    <time_frame>Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21</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. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale</measure>
    <time_frame>Baseline, Week 8, and Week 21</time_frame>
    <description>The PSP is a clinician rated instrument providing an overall rating of personal and social functioning in patients with schizophrenia on a scale of 1-100. The scale defines a continuum from grossly impaired functioning, in which total lack of autonomy in basic functioning and survival risk is evident, to excellent functioning. 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>Score of Mediation Adherence Rating Scale (MARS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The MARS is a 10-items self-rating scale to measure the adherence of the drug medication for psychosis. Each item is answered &quot;yes/no&quot; and the total score ranges from 0 points (Low medication adherence) to 10 points (High medication adherence).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Group 1 (Immediate switch)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Delayed switch)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Current oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paliperidone palmitate</intervention_name>
    <description>Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent.</description>
    <arm_group_label>Group 1 (Immediate switch)</arm_group_label>
    <arm_group_label>Group 2 (Delayed switch)</arm_group_label>
    <other_name>INVEGA SUSTENNA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:- Meet diagnostic criteria for schizophrenia according to Diagnostic and&#xD;
        Statistical Manual of Mental Disorders Version IV&#xD;
&#xD;
          -  Dissatisfied with current medication (Medication Satisfaction Questionnaire score of&#xD;
             less than or equal to 4) or by clinician's judgment and who may benefit from switching&#xD;
             medication&#xD;
&#xD;
          -  Have received an oral antipsychotic for at least 4 weeks before randomization&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History of neuroleptic malignant syndrome&#xD;
&#xD;
          -  Presence of congenital prolongation of the QT interval - History of treatment with&#xD;
             depot antipsychotics, including long-acting injectable risperidone and paliperidone&#xD;
             palmitate, within 90 days of the screening visit; or any treatment with clozapine&#xD;
             within the previous 60 days&#xD;
&#xD;
          -  Any relevant medical history or current presence of systemic disease&#xD;
&#xD;
          -  Significant risk of suicidal, homicidal or violent ideation or behavior as clinically&#xD;
             assessed by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Korea, Ltd., Korea Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Korea, Ltd., Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Buchun</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cheonan City</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chungcheongbuk-Do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyeonggi-Do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seognam-Si, Kyungki-Do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&amp;studyid=3405&amp;filename=CR100740_CSR.pdf</url>
    <description>An open-label, comparative study of immediate or delayed switch to paliperidone palmitate in patients unsatisfied with current oral atypical antipsychotics to evaluate the evolution of medication satisfaction and adherence</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Paliperidone Palmitate</keyword>
  <keyword>Invega Sustenna</keyword>
  <keyword>Antipsychotics</keyword>
  <keyword>Atypical antipsychotics</keyword>
  <keyword>Medication Satisfaction and Adherence</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>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/NCT01682161
org study id: CR100740
secondary id: R092670SCH4010
secondary id: PALM-KOR-4001
nct id: NCT01682161
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the change of medication satisfaction measured by
      Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are
      switched into paliperidone palmitate, either immediately or in a delayed mode.
This is a prospective (patients are first identified and then followed forward as time
      passes), multicenter (study conducted at multiple sites), randomized (the study medication is
      assigned by chance), comparative and open-labeled (all people know the identity of the
      intervention) study.

      The study mainly consists of 3 phases including, the screening phase (14 days before
      administration of study medication), treatment phase, and the follow-up phase (28 days after
      the last dose of the study medication). In the treatment phase, patients will be randomly
      assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown
      characteristics. Group 1 (immediate switch group): Patients will be administered with
      paliperidone palmitate immediately after randomization and will continue throughout the
      treatment phase. Group 2 (delayed switch group): Patients will remain on current oral
      antipsychotics until Week 8, and later on will be completely switched to paliperidone
      palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further
      deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.

      Safety evaluations will include evaluation of adverse events, clinical laboratory tests,
      electrocardiogram, vital signs, and physical examination and these will be monitored
      throughout the study.

      The total duration of the study will be approximately 148 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)
time frame: Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
description: MSQ is designed to assess treatment satisfaction among patients with schizophrenia. The responses will be assessed on a 7-point Likert-type 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.
measure: Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
time frame: Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
description: The TSQM is a 14-item subject assessed evaluation of treatment medication using a 7-point Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7= Extremely Satisfied.
measure: Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)
time frame: Baseline, Week 8, and Week 21
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. Each item is rated as follows: 1=absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate Severe, 6=Severe, and 7=Extreme.
measure: Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale
time frame: Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
description: The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill.
measure: Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale
time frame: Baseline, Week 8, and Week 21
description: The PSP is a clinician rated instrument providing an overall rating of personal and social functioning in patients with schizophrenia on a scale of 1-100. The scale defines a continuum from grossly impaired functioning, in which total lack of autonomy in basic functioning and survival risk is evident, to excellent functioning. 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: Score of Mediation Adherence Rating Scale (MARS)
time frame: Baseline
description: The MARS is a 10-items self-rating scale to measure the adherence of the drug medication for psychosis. Each item is answered "yes/no" and the total score ranges from 0 points (Low medication adherence) to 10 points (High medication adherence).
arm group label: Group 1 (Immediate switch)
arm group type: Experimental
description: Paliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase.
arm group label: Group 2 (Delayed switch)
arm group type: Experimental
description: Current oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered.
intervention type: Drug
intervention name: Paliperidone palmitate
description: Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent.
arm group label: Group 1 (Immediate switch)
arm group label: Group 2 (Delayed switch)
other name: INVEGA SUSTENNA
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Janssen Korea, Ltd., Korea Clinical Trial
role: Study Director
affiliation: Janssen Korea, Ltd., Korea
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3405&filename=CR100740_CSR.pdf
description: An open-label, comparative study of immediate or delayed switch to paliperidone palmitate in patients unsatisfied with current oral atypical antipsychotics to evaluate the evolution of medication satisfaction and adherence
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Paliperidone Palmitate