<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/NCT01685931</url>
  </required_header>
  <id_info>
    <org_study_id>CR100880</org_study_id>
    <secondary_id>R092670SCH4019</secondary_id>
    <nct_id>NCT01685931</nct_id>
  </id_info>
  <brief_title>A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics</brief_title>
  <official_title>Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter, Prospective, Interventional Study Followed by a Naturalistic Additional 1 Year Follow up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xian-Janssen Pharmaceutical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xian-Janssen Pharmaceutical Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly&#xD;
      dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated&#xD;
      by oral antipsychotics and with acute symptom of schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 13-week, open-label (all people know the identity of the intervention), single-arm&#xD;
      (one group of patients), multicenter, prospective, interventional study in Chinese patients.&#xD;
      In a prospective, interventional study, the patients identified receive a treatment during&#xD;
      the course of the research study and are followed forward in time for the outcome of the&#xD;
      study. In China, there is still insufficient information about effectiveness, tolerability,&#xD;
      and dosage strategy for directly switching from previous oral antipsychotics (drugs that are&#xD;
      helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in&#xD;
      patients with acute symptoms. Acute symptoms are quick and severe form of illness in its&#xD;
      early stage. In addition, there is also lack of information about bridging acute phase to&#xD;
      long-term treatment. In this study, patients with multiple types of acute schizophrenia will&#xD;
      be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks.&#xD;
      After the acute treatment, the patients will continue to receive the prescribed medication&#xD;
      and will be followed up for an additional 52 weeks to assess the outcomes related to&#xD;
      long-term treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>Baseline, Week 13</time_frame>
    <description>The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in Positive and Negative Syndrome Scale (PANSS) score</measure>
    <time_frame>Baseline, Week 13</time_frame>
    <description>The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in Clinical Global Impression - Severity (CGI-S)</measure>
    <time_frame>Baseline, Week 13</time_frame>
    <description>The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to &quot;Normal, not at all ill&quot; and a rating of 7 is equivalent to &quot;Among the most extremely ill patients&quot;. Higher scores indicate worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in Medication Satisfaction Questionnaire (MSQ)</measure>
    <time_frame>Baseline, Week 13</time_frame>
    <description>The MSQ is a 7-point, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied or Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in Involvement Evaluation Questionnaire (IEQ)</measure>
    <time_frame>Baseline, Week 13</time_frame>
    <description>The IEQ is a 31-item questionnaire that assesses the encouragement and care that the caregiver has to give to the patient, to personal problems between patient and caregiver, and to the caregiver's worries, coping and subjective burden. All items are scored on 5-point Likert scales (never, sometimes, regularly, often, always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in Medication Adherence Rating Scale (MARS)</measure>
    <time_frame>Baseline, Week 13</time_frame>
    <description>The MARS is a ten-item yes/no self-report measure of medication adherence in psychosis. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood of medication adherence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in Medication Preference Questionnaire (MPQ)</measure>
    <time_frame>Baseline, Week 13</time_frame>
    <description>The MPQ is used to investigate which treatment (oral or injection) the patients prefer and why they prefer this treatment, and to investigate which injectable site (deltoid or gluteal) they prefer and why they prefer this treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">617</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Paliperidone Palmitate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paliperidone Palmitate</intervention_name>
    <description>One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.</description>
    <arm_group_label>Paliperidone Palmitate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous diagnosis of schizophrenia&#xD;
&#xD;
          -  Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS)&#xD;
             total score between 70 and 120, inclusive&#xD;
&#xD;
          -  Patients currently treated with antipsychotic are allowed to be recruited&#xD;
&#xD;
          -  Be medically stable on the basis of clinical laboratory tests performed at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A primary diagnosis other than schizophrenia&#xD;
&#xD;
          -  History of risperidone or paliperidone resistance as defined by failure to respond to&#xD;
             2 adequate treatment periods&#xD;
&#xD;
          -  Clozapine use for treatment refractory schizophrenia&#xD;
&#xD;
          -  Relevant history or current presence of any significant or unstable condition, disease&#xD;
             or illness that could limit the participation in the study according to the&#xD;
             investigator&#xD;
&#xD;
          -  Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xian-Janssen Pharmaceutical Ltd., China Clinical trial</last_name>
    <role>Study Director</role>
    <affiliation>Xian-Janssen Pharmaceutical Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Baoding</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Qingdao</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shantou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&amp;studyid=3548&amp;filename=CR100880_CSR.pdf</url>
    <description>A Study of Paliperidone Palmitate in Patients with Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>January 25, 2016</last_update_submitted>
  <last_update_submitted_qc>January 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Paliperidone Palmitate</keyword>
  <keyword>Oral Antipsychotics</keyword>
  <keyword>Invega Sustenna</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/NCT01685931
org study id: CR100880
secondary id: R092670SCH4019
nct id: NCT01685931
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly
      dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated
      by oral antipsychotics and with acute symptom of schizophrenia.
This is a 13-week, open-label (all people know the identity of the intervention), single-arm
      (one group of patients), multicenter, prospective, interventional study in Chinese patients.
      In a prospective, interventional study, the patients identified receive a treatment during
      the course of the research study and are followed forward in time for the outcome of the
      study. In China, there is still insufficient information about effectiveness, tolerability,
      and dosage strategy for directly switching from previous oral antipsychotics (drugs that are
      helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in
      patients with acute symptoms. Acute symptoms are quick and severe form of illness in its
      early stage. In addition, there is also lack of information about bridging acute phase to
      long-term treatment. In this study, patients with multiple types of acute schizophrenia will
      be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks.
      After the acute treatment, the patients will continue to receive the prescribed medication
      and will be followed up for an additional 52 weeks to assess the outcomes related to
      long-term treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)
time frame: Baseline, Week 13
description: The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
measure: The change from baseline in Positive and Negative Syndrome Scale (PANSS) score
time frame: Baseline, Week 13
description: The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
measure: The change from baseline in Clinical Global Impression - Severity (CGI-S)
time frame: Baseline, Week 13
description: The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.
measure: The change from baseline in Medication Satisfaction Questionnaire (MSQ)
time frame: Baseline, Week 13
description: The MSQ is a 7-point, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied or Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
measure: The change from baseline in Involvement Evaluation Questionnaire (IEQ)
time frame: Baseline, Week 13
description: The IEQ is a 31-item questionnaire that assesses the encouragement and care that the caregiver has to give to the patient, to personal problems between patient and caregiver, and to the caregiver's worries, coping and subjective burden. All items are scored on 5-point Likert scales (never, sometimes, regularly, often, always).
measure: The change from baseline in Medication Adherence Rating Scale (MARS)
time frame: Baseline, Week 13
description: The MARS is a ten-item yes/no self-report measure of medication adherence in psychosis. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood of medication adherence).
measure: The change from baseline in Medication Preference Questionnaire (MPQ)
time frame: Baseline, Week 13
description: The MPQ is used to investigate which treatment (oral or injection) the patients prefer and why they prefer this treatment, and to investigate which injectable site (deltoid or gluteal) they prefer and why they prefer this treatment.
arm group label: Paliperidone Palmitate
arm group type: Experimental
intervention type: Drug
intervention name: Paliperidone Palmitate
description: One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.
arm group label: Paliperidone Palmitate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xian-Janssen Pharmaceutical Ltd., China Clinical trial
role: Study Director
affiliation: Xian-Janssen Pharmaceutical Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=3548&filename=CR100880_CSR.pdf
description: A Study of Paliperidone Palmitate in Patients with Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Paliperidone Palmitate