<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/NCT01662648</url>
  </required_header>
  <id_info>
    <org_study_id>CR013534</org_study_id>
    <secondary_id>R076477SCH3024</secondary_id>
    <nct_id>NCT01662648</nct_id>
  </id_info>
  <brief_title>Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia</brief_title>
  <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 Pharmaceutica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the efficacy of flexibly dosed paliperidone&#xD;
      extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms&#xD;
      of emotional instability, detachment from reality, often with delusions and hallucinations,&#xD;
      and withdrawal into the self) who were previously unsuccessfully treated with other oral&#xD;
      antipsychotics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm (one group of participants), multi-center, 6-month study to explore the&#xD;
      tolerability, safety and efficacy of flexibly dosed paliperidone ER in participants with&#xD;
      schizophrenia previously unsuccessfully treated with an oral antipsychotic medication.&#xD;
      Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a&#xD;
      capacity to ameliorate thought disorders. Unsuccessfully treated means that, despite the&#xD;
      participant was treated with an adequate dose of an appropriate oral antipsychotic for an&#xD;
      adequate period of time, previous treatment is considered unsuccessful due to lack of&#xD;
      efficacy, lack of tolerability or safety, lack of compliance and/or other reasons. Throughout&#xD;
      the study the investigators will adjust the dosage of each participant based on the&#xD;
      individual needs. In general, the recommended paliperidone ER dose will be 6 milligram once&#xD;
      daily. Participants can be either in- or outpatients and they may take their study drug with&#xD;
      or without food. Participants who will complete this 6-month study and would like to continue&#xD;
      will be eligible to be enrolled in an extension phase until paliperidone ER is available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">April 2009</completion_date>
  <primary_completion_date type="Actual">April 2008</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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 Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PANSS Total Positive Subscale Score at Week 26</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PANSS Total Negative Subscale Score at Week 26</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) 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, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to &quot;normal, not at all ill&quot; and a rating of 7 indicates &quot;among the most extremely ill participants&quot;. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>The PSP scale assesses the degree of 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 (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sleep Quality at Week 26</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Daytime Drowsiness at Week 26</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: &quot;not at all&quot; to 100:&quot;all the time&quot;). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Within Each Category of Patient Satisfaction Score</measure>
    <time_frame>Baseline and Week 26</time_frame>
    <description>Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1117</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Paliperidone ER: Lack of efficacy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paliperidone ER: Lack of tolerability, compliance or other</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paliperidone ER</intervention_name>
    <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.</description>
    <arm_group_label>Paliperidone ER: Lack of efficacy</arm_group_label>
    <arm_group_label>Paliperidone ER: Lack of tolerability, compliance or other</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant diagnosed with schizophrenia&#xD;
&#xD;
          -  Participant's previous treatment of schizophrenia is considered unsuccessful&#xD;
&#xD;
          -  Participant is healthy on the basis of a physical examination and vital signs&#xD;
&#xD;
          -  Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active,&#xD;
             agree to practice an effective method of birth control before entry and throughout the&#xD;
             study&#xD;
&#xD;
          -  Be willing and able to fill out self-administered questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have used clozapine or Risperdal CONSTA during the last month, or have received any&#xD;
             other conventional drug used to treat psychosis during the last 3 months&#xD;
&#xD;
          -  Judged to be at high risk for adverse events, violence or self-harm&#xD;
&#xD;
          -  Inability to swallow the study medication whole with the aid of water&#xD;
&#xD;
          -  Pregnant or breast-feeding female&#xD;
&#xD;
          -  History or current symptoms of tardive dyskinesia (involuntary movements of the facial&#xD;
             muscles and tongue)&#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 Pharmaceutica Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica</affiliation>
  </overall_official>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>December 17, 2013</results_first_submitted>
  <results_first_submitted_qc>February 28, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 26, 2014</results_first_posted>
  <last_update_submitted>April 17, 2014</last_update_submitted>
  <last_update_submitted_qc>April 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Paliperidone</keyword>
  <keyword>Paliperidone extended-release (ER)</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>
      <group_list>
        <group group_id="P1">
          <title>Paliperidone ER: Lack of Efficacy</title>
          <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
        </group>
        <group group_id="P2">
          <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
          <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="520"/>
                <participants group_id="P2" count="597"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="373"/>
                <participants group_id="P2" count="419"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="178"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant ineligible to continue trial</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant non-compliant</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event and lack of efficacy (LOE)</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>LOE and other reason unspecified</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>LOE and Participant non-compliant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Paliperidone ER: Lack of Efficacy</title>
          <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
        </group>
        <group group_id="B2">
          <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
          <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="520"/>
            <count group_id="B2" value="597"/>
            <count group_id="B3" value="1117"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Less than (&lt;) 25 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92" spread="11.63"/>
                    <measurement group_id="B2" value="125" spread="11.90"/>
                    <measurement group_id="B3" value="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greater than or equal to (&gt;=) 25 to &lt; 35 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 35 to &lt; 45 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 45 to &lt; 55 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 55 to &lt; 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 65 to &lt; 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greater than 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="192"/>
                    <measurement group_id="B2" value="268"/>
                    <measurement group_id="B3" value="460"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="328"/>
                    <measurement group_id="B2" value="329"/>
                    <measurement group_id="B3" value="657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26</title>
        <description>The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26</title>
          <description>The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>units 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="508"/>
                <count group_id="O2" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.19" spread="24.97"/>
                    <measurement group_id="O2" value="65.45" spread="28.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.60" spread="28.24"/>
                    <measurement group_id="O2" value="-20.52" spread="30.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26</title>
        <description>The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26</title>
          <description>The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="508"/>
                <count group_id="O2" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.83"/>
                    <measurement group_id="O2" value="71.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PANSS Total Positive Subscale Score at Week 26</title>
        <description>The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PANSS Total Positive Subscale Score at Week 26</title>
          <description>The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>units 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="508"/>
                <count group_id="O2" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.04" spread="7.15"/>
                    <measurement group_id="O2" value="15.26" spread="7.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.17" spread="7.67"/>
                    <measurement group_id="O2" value="-5.07" spread="7.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PANSS Total Negative Subscale Score at Week 26</title>
        <description>The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) 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, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PANSS Total Negative Subscale Score at Week 26</title>
          <description>The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) 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, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>units 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="508"/>
                <count group_id="O2" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.73" spread="7.86"/>
                    <measurement group_id="O2" value="16.90" spread="8.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.93" spread="7.96"/>
                    <measurement group_id="O2" value="-5.32" spread="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26</title>
        <description>The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to &quot;normal, not at all ill&quot; and a rating of 7 indicates &quot;among the most extremely ill participants&quot;. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26</title>
          <description>The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to &quot;normal, not at all ill&quot; and a rating of 7 indicates &quot;among the most extremely ill participants&quot;. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>units 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="508"/>
                <count group_id="O2" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.24" spread="0.83"/>
                    <measurement group_id="O2" value="3.29" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" spread="1.28"/>
                    <measurement group_id="O2" value="-0.98" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26</title>
        <description>The PSP scale assesses the degree of 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 (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26</title>
          <description>The PSP scale assesses the degree of 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 (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.</population>
          <units>units 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="506"/>
                <count group_id="O2" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 506, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.07" spread="15.68"/>
                    <measurement group_id="O2" value="66.03" spread="15.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 501, 574)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.76" spread="17.80"/>
                    <measurement group_id="O2" value="11.14" spread="17.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sleep Quality at Week 26</title>
        <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sleep Quality at Week 26</title>
          <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.</population>
          <units>millimeter (mm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="507"/>
                <count group_id="O2" value="581"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 507, 581)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.53" spread="27.37"/>
                    <measurement group_id="O2" value="67.40" spread="27.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 504, 574)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.57" spread="35.70"/>
                    <measurement group_id="O2" value="8.19" spread="35.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Daytime Drowsiness at Week 26</title>
        <description>Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: &quot;not at all&quot; to 100:&quot;all the time&quot;). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Daytime Drowsiness at Week 26</title>
          <description>Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: &quot;not at all&quot; to 100:&quot;all the time&quot;). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.</population>
          <units>millimeter (mm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="507"/>
                <count group_id="O2" value="581"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 507, 581 )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.80" spread="27.56"/>
                    <measurement group_id="O2" value="34.54" spread="28.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 (n= 504, 574)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.52" spread="32.29"/>
                    <measurement group_id="O2" value="-11.54" spread="34.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Within Each Category of Patient Satisfaction Score</title>
        <description>Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
        <time_frame>Baseline and Week 26</time_frame>
        <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.&quot;N&quot; (number of participants analyzed) signifies participants evaluable for this measure and &quot;n&quot; signifies those participants who were evaluated for this measure at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone ER: Lack of Efficacy</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
          </group>
          <group group_id="O2">
            <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
            <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Within Each Category of Patient Satisfaction Score</title>
          <description>Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.</description>
          <population>ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.&quot;N&quot; (number of participants analyzed) signifies participants evaluable for this measure and &quot;n&quot; signifies those participants who were evaluated for this measure at specified 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="507"/>
                <count group_id="O2" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Good: Baseline (n= 507, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="32.74"/>
                    <measurement group_id="O2" value="21" spread="34.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good: Baseline (n= 507, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reasonable: Baseline (n= 507, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="256"/>
                    <measurement group_id="O2" value="305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate: Baseline (n= 507, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor: Baseline (n= 507, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Good: Week 26 (n=492, 563)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good: Week 26 (n=492, 563)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reasonable: Week 26 (n=492, 563)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate: Week 26 (n=492, 563)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor: Week 26 (n=492, 563)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>26 weeks</time_frame>
      <desc>Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.</desc>
      <group_list>
        <group group_id="E1">
          <title>Paliperidone ER: Lack of Efficacy</title>
          <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.</description>
        </group>
        <group group_id="E2">
          <title>Paliperidone ER: Lack of Tolerability, Compliance or Other</title>
          <description>Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Oculogyration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Extrapyramidal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Suicidal behaviour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Abnormal behaviour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Delusion of grandeur</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Grandiosity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Hallucination, auditory</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Hostility</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Schizoaffective disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Schizophrenia, disorganized type</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Acute psychosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="208" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="239" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Oculogyration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Extrapyramidal disorder</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Parkinsonism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="587"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="587"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="587"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Regional Medical Franchis Director AP</name_or_title>
      <organization>Janssen China</organization>
      <phone>+86 10 582 187 66</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/NCT01662648
org study id: CR013534
secondary id: R076477SCH3024
nct id: NCT01662648
lead sponsor: 
has dmc: No
The purpose of this study is to explore the efficacy of flexibly dosed paliperidone
      extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms
      of emotional instability, detachment from reality, often with delusions and hallucinations,
      and withdrawal into the self) who were previously unsuccessfully treated with other oral
      antipsychotics.
This is a single arm (one group of participants), multi-center, 6-month study to explore the
      tolerability, safety and efficacy of flexibly dosed paliperidone ER in participants with
      schizophrenia previously unsuccessfully treated with an oral antipsychotic medication.
      Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a
      capacity to ameliorate thought disorders. Unsuccessfully treated means that, despite the
      participant was treated with an adequate dose of an appropriate oral antipsychotic for an
      adequate period of time, previous treatment is considered unsuccessful due to lack of
      efficacy, lack of tolerability or safety, lack of compliance and/or other reasons. Throughout
      the study the investigators will adjust the dosage of each participant based on the
      individual needs. In general, the recommended paliperidone ER dose will be 6 milligram once
      daily. Participants can be either in- or outpatients and they may take their study drug with
      or without food. Participants who will complete this 6-month study and would like to continue
      will be eligible to be enrolled in an extension phase until paliperidone ER is available.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
time frame: Baseline and Week 26
description: The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26
time frame: Week 26
description: The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Change From Baseline in PANSS Total Positive Subscale Score at Week 26
time frame: Baseline and Week 26
description: The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Change From Baseline in PANSS Total Negative Subscale Score at Week 26
time frame: Baseline and Week 26
description: The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) 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, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26
time frame: Baseline and Week 26
description: The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26
time frame: Baseline and Week 26
description: The PSP scale assesses the degree of 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 (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Change From Baseline in Sleep Quality at Week 26
time frame: Baseline and Week 26
description: Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Change From Baseline in Daytime Drowsiness at Week 26
time frame: Baseline and Week 26
description: Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: "not at all" to 100:"all the time"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
measure: Number of Participants Within Each Category of Patient Satisfaction Score
time frame: Baseline and Week 26
description: Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
arm group label: Paliperidone ER: Lack of efficacy
arm group type: Experimental
description: Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
arm group label: Paliperidone ER: Lack of tolerability, compliance or other
arm group type: Experimental
description: Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
intervention type: Drug
intervention name: Paliperidone ER
description: Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.
arm group label: Paliperidone ER: Lack of efficacy
arm group label: Paliperidone ER: Lack of tolerability, compliance or other
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Pharmaceutica Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Paliperidone Palmitate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 