<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/NCT01724359</url>
  </required_header>
  <id_info>
    <org_study_id>CR017413</org_study_id>
    <secondary_id>R076477SCH3029</secondary_id>
    <secondary_id>R076477SCH3036</secondary_id>
    <nct_id>NCT01724359</nct_id>
  </id_info>
  <brief_title>Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia</brief_title>
  <acronym>PERFLEX</acronym>
  <official_title>An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag, S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag, S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate efficacy, safety and tolerability of flexible,&#xD;
      once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from&#xD;
      Argentina and Colombia that previously failed treatment with other antipsychotic agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm (one group of patients), open-label (all people know the identity of the&#xD;
      intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone&#xD;
      ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to&#xD;
      adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6,&#xD;
      9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally.&#xD;
      Adjustment of the dosage will be done at the investigator's discretion, based on the&#xD;
      individual patient's clinical response and tolerability to the study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">November 2009</completion_date>
  <primary_completion_date type="Actual">November 2009</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>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. 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 and ranges from 30 to 210. Higher scores indicate worsening.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression-Severity (CGIS)</measure>
    <time_frame>Baseline, Week 26</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>Personal and Social Performance (PSP) Scale</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =&lt; 30, functioning so poorly as to require intensive supervision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Status as Measured by Self-rated Health Status Survey SF-36</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Evaluation Scale</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime Drowsiness Evaluation Scale</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Paliperidone ER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paliperidone ER</intervention_name>
    <description>The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.</description>
    <arm_group_label>Paliperidone ER</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient meets the criteria for schizophrenia&#xD;
&#xD;
          -  Patient is previously non-acute and has been given an adequate dose of an appropriate&#xD;
             oral antipsychotic for an adequate period of time prior to enrollment, but previous&#xD;
             treatment is considered unsuccessful due to one or more of the following reasons: lack&#xD;
             of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons&#xD;
             to switch to another antipsychotic medication&#xD;
&#xD;
          -  Patient is healthy on the basis of a physical examination and vital signs at screening&#xD;
&#xD;
          -  Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or,&#xD;
             if sexually active, agree to practice an effective method of birth control before&#xD;
             entry and throughout the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting&#xD;
             injections during the last 3 months&#xD;
&#xD;
          -  Patients with serious unstable medical condition, including known clinically relevant&#xD;
             laboratory abnormalities&#xD;
&#xD;
          -  Patients with history or current symptoms of tardive dyskinesia and neuroleptic&#xD;
             malignant syndrome&#xD;
&#xD;
          -  Patients judged to be at high risk for adverse events, violence, or self-harm&#xD;
&#xD;
          -  Patients with known hypersensitivity to paliperidone ER or to risperidone&#xD;
&#xD;
          -  Patients with a current use or known history (over the past 6 months) of substance&#xD;
             dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag S.A. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag, S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Buenos Aires N/A</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rosario</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Medellin</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Colombia</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <results_first_submitted>November 27, 2012</results_first_submitted>
  <results_first_submitted_qc>February 4, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 15, 2013</results_first_posted>
  <last_update_submitted>February 4, 2013</last_update_submitted>
  <last_update_submitted_qc>February 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Paliperidone extended-release (ER)</keyword>
  <keyword>Antipsychotic agents</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Patients who received paliperidone extended-release (ER) at least once and provide at least 1 post baseline efficacy measurement will be included in the intent-to-treat (ITT) analysis set for efficacy. Patients who received paliperidone ER at least once and provide any post-baseline information will be included in the ITT analysis set for safety.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Paliperidone Extended-release (ER)</title>
          <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Paliperidone Extended-release (ER)</title>
          <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="95"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.86" spread="12.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colombia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score</title>
        <description>The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. 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 and ranges from 30 to 210. Higher scores indicate worsening.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score</title>
          <description>The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. 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 and ranges from 30 to 210. Higher scores indicate worsening.</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.99" spread="22.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.70" spread="18.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score</title>
        <description>The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score</title>
          <description>The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.53" spread="7.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.16" spread="4.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score</title>
        <description>The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score</title>
          <description>The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.69" spread="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.64" spread="5.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score</title>
        <description>The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score</title>
          <description>The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.77" spread="11.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.90" spread="10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression-Severity (CGIS)</title>
        <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>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients at Baseline: Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
          <group group_id="O2">
            <title>Patients at Week 26: Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression-Severity (CGIS)</title>
          <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>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal, not at all ill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Borderline mentally ill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mildly ill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately ill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Markedly ill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely ill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Among the most extremely ill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Personal and Social Performance (PSP) Scale</title>
        <description>This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =&lt; 30, functioning so poorly as to require intensive supervision.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Personal and Social Performance (PSP) Scale</title>
          <description>This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =&lt; 30, functioning so poorly as to require intensive supervision.</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 95)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.06" spread="15.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 78)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.24" spread="15.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Status as Measured by Self-rated Health Status Survey SF-36</title>
        <description>The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Status as Measured by Self-rated Health Status Survey SF-36</title>
          <description>The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 95)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.39" spread="18.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.02" spread="21.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Evaluation Scale</title>
        <description>This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Evaluation Scale</title>
          <description>This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.80" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.66" spread="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daytime Drowsiness Evaluation Scale</title>
        <description>This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone Extended-release (ER)</title>
            <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Daytime Drowsiness Evaluation Scale</title>
          <description>This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).</description>
          <population>All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.68" spread="3.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.58" spread="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Paliperidone Extended-release (ER)</title>
          <description>The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Clinical deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic episode</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Major depressive disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Worsening of the psychiatric condition with aggressive behavior</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Parkinsonism</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GERENTE MEDICO REGIONAL</name_or_title>
      <organization>Jan-Cil Mexico</organization>
      <phone>52 55 5237 3410</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT01724359
org study id: CR017413
secondary id: R076477SCH3029
secondary id: R076477SCH3036
nct id: NCT01724359
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible,
      once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from
      Argentina and Colombia that previously failed treatment with other antipsychotic agents.
This is a single arm (one group of patients), open-label (all people know the identity of the
      intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone
      ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to
      adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6,
      9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally.
      Adjustment of the dosage will be done at the investigator's discretion, based on the
      individual patient's clinical response and tolerability to the study drug.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
time frame: Baseline, Week 26
description: The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. 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 and ranges from 30 to 210. Higher scores indicate worsening.
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
time frame: Baseline, Week 26
description: The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
time frame: Baseline, Week 26
description: The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
time frame: Baseline, Week 26
description: The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
measure: Clinical Global Impression-Severity (CGIS)
time frame: Baseline, Week 26
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: Personal and Social Performance (PSP) Scale
time frame: Baseline, Week 26
description: This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
measure: Health Status as Measured by Self-rated Health Status Survey SF-36
time frame: Baseline, Week 26
description: The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.
measure: Sleep Evaluation Scale
time frame: Baseline, Week 26
description: This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).
measure: Daytime Drowsiness Evaluation Scale
time frame: Baseline, Week 26
description: This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).
arm group label: Paliperidone ER
arm group type: Experimental
intervention type: Drug
intervention name: Paliperidone ER
description: The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.
arm group label: Paliperidone ER
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen-Cilag S.A. Clinical Trial
role: Study Director
affiliation: Janssen-Cilag, S.A.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Colombia
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Paliperidone Palmitate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 