<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/NCT01662310</url>
  </required_header>
  <id_info>
    <org_study_id>CR100427</org_study_id>
    <secondary_id>R076477-SCH-3041</secondary_id>
    <nct_id>NCT01662310</nct_id>
  </id_info>
  <brief_title>An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia</brief_title>
  <official_title>Paliperidone Extended Release Tablets for the Prevention of Relapse in Subjects With Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, tolerability and safety of&#xD;
      paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in&#xD;
      the prevention of relapse in schizophrenia participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind (neither physician nor participant knows the name of the assigned&#xD;
      drug), randomized (participants are assigned to treatment by a chance), placebo-controlled,&#xD;
      and parallel-group study of paliperidone ER tablets. The study will consist of 6 phases: 14&#xD;
      days of screening phase, 8 weeks of open-label run-in phase (participants will be flexibly&#xD;
      dosed with paliperidone ER once daily in a dose range of 3 mg to 12 mg), 6 weeks of&#xD;
      stabilization phase (participants will continue to receive the fixed dose of paliperidone&#xD;
      ER), double-blind (DB) phase of various length (participants will be randomly assigned in a&#xD;
      1:1 ratio to receive either paliperidone ER or placebo and this phase will be completed after&#xD;
      86 relapse events are observed or if the study is positive at the interim analysis), 6 months&#xD;
      of open-label extension (participants who experience a relapse event or who remain relapse&#xD;
      free for the entire duration of the double-blind phase and participants who are enrolled at&#xD;
      the time the study is terminated, will be eligible for this phase. All participants will be&#xD;
      treated with paliperidone ER and safety and tolerability information will be collected during&#xD;
      this phase) phase and 6 months of follow-up phase (participants who withdraw during the DB&#xD;
      phase for any reason other than relapse will be followed for 6 months or until they&#xD;
      experience a relapse). Participants' safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Double Blind (DB) Phase: Median Time to Relapse</measure>
    <time_frame>DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)</time_frame>
    <description>A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14</measure>
    <time_frame>Baseline and Week 14</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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint</measure>
    <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</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. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)</measure>
    <time_frame>Baseline and Week 14</time_frame>
    <description>The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint</measure>
    <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
    <description>CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14</measure>
    <time_frame>Baseline and Week 14</time_frame>
    <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint</measure>
    <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
    <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14</measure>
    <time_frame>Baseline and Week 14</time_frame>
    <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint</measure>
    <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
    <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14</measure>
    <time_frame>Baseline and Week 14</time_frame>
    <description>Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint</measure>
    <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
    <description>Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)</measure>
    <time_frame>DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)</time_frame>
    <description>A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint</measure>
    <time_frame>OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)</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. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint</measure>
    <time_frame>OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)</time_frame>
    <description>CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint</measure>
    <time_frame>OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)</time_frame>
    <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Paliperidone: Run-in or Stabilization phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose will be increased from milligram per day (3 mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paliperidone: Double blind (DB) phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo: DB phase</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paliperidone</intervention_name>
    <description>Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day.</description>
    <arm_group_label>Paliperidone: Double blind (DB) phase</arm_group_label>
    <arm_group_label>Paliperidone: Run-in or Stabilization phase</arm_group_label>
    <other_name>R076477</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study.</description>
    <arm_group_label>Placebo: DB phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of&#xD;
             Mental Disorders, 4th Edition (DSM-IV)&#xD;
&#xD;
          -  Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS)&#xD;
             total score between 70 and 120 inclusive, at Screening and Baseline&#xD;
&#xD;
          -  Women must be postmenopausal (for at least 1 year), surgically sterile (have had a&#xD;
             hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of&#xD;
             pregnancy), practicing a highly effective method of birth control, if sexually active&#xD;
&#xD;
          -  Men must be using a highly effective method of birth control and must not donate sperm&#xD;
             during the study and for 3 months after receiving the last dose of study drug&#xD;
&#xD;
          -  Be willing and capable to complete the questionnaires and able to take oral&#xD;
             medications independently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine&#xD;
             dependence) within 6 months before screening&#xD;
&#xD;
          -  Participants with Crohn's disease and hepatic or renal diseases&#xD;
&#xD;
          -  Has had relevant history of any significant and/or unstable cardiovascular,&#xD;
             respiratory, neurologic (including seizures or significant cerebrovascular&#xD;
             dysfunction), renal, hepatic, endocrine, or immunologic diseases&#xD;
&#xD;
          -  Has had history of neuroleptic malignant syndrome (the disorder caused by&#xD;
             antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)&#xD;
&#xD;
          -  Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms&#xD;
             of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin,&#xD;
             carbamazepine, barbiturates, or lamotrigine&#xD;
&#xD;
          -  Had been treated with clozapine for treatment refractory or treatment resistant&#xD;
             schizophrenia&#xD;
&#xD;
          -  Has significant risk of suicide or homicidal behavior, or significant risk of&#xD;
             deliberate self harm or harm to others&#xD;
&#xD;
          -  Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks&#xD;
             before screening&#xD;
&#xD;
          -  Has received electroconvulsive therapy within 60 days before screening&#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 Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Baoding</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Xi'An</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Xian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Xinxiang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>March 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>April 30, 2014</results_first_submitted>
  <results_first_submitted_qc>April 30, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 6, 2014</results_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 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</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: Run-in or Stabilization Phase</title>
          <description>Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
        </group>
        <group group_id="P2">
          <title>Paliperidone: Double Blind (DB) Phase</title>
          <description>Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
        </group>
        <group group_id="P3">
          <title>Placebo: DB Phase</title>
          <description>Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.</description>
        </group>
        <group group_id="P4">
          <title>Paliperidone DB/Paliperidone Open-label (OL) Extension Phase</title>
          <description>Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
        </group>
        <group group_id="P5">
          <title>Placebo DB/Paliperidone OL Extension Phase</title>
          <description>Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Run-In or Stabilization Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="201"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Double-Blind Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="71"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="71"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Extension Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="36"/>
                <participants group_id="P5" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Entire Study Population</title>
          <description>All the participants who were enrolled.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="201"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.3" spread="10.52"/>
                  </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="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Double Blind (DB) Phase: Median Time to Relapse</title>
        <description>A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.</description>
        <time_frame>DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)</time_frame>
        <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Double Blind (DB) Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: DB Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Blind (DB) Phase: Median Time to Relapse</title>
          <description>A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.</description>
          <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.</measurement>
                    <measurement group_id="O2" value="49.0" lower_limit="22.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14</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.</description>
        <time_frame>Baseline and Week 14</time_frame>
        <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Run-in or Stabilization Phase</title>
            <description>Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14</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.</description>
          <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values.</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="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.5" spread="12.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14 (n=200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.8" spread="18.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint</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. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
        <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
        <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Double Blind (DB) Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: DB Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint</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. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
          <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.</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="64"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="9.71" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="51.5" spread="9.50" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at DB endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="12.67"/>
                    <measurement group_id="O2" value="16.9" spread="16.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)</title>
        <description>The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.</description>
        <time_frame>Baseline and Week 14</time_frame>
        <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Run-in or Stabilization Phase</title>
            <description>Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)</title>
          <description>The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.</description>
          <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the 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="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not ill: Baseline (n=201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="12.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not ill: Week 14 (n= 135)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="18.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Mild: Baseline (n= 201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Mild: Week 14 (n= 135)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild: Baseline (n= 201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild: Week 14 (n= 135)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate: Baseline (n= 201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate: Week 14 (n= 135)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marked: Baseline (n= 201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Marked: Week 14 (n= 135)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Baseline (n= 201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe: Week 14 (n= 135)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely Severe: Baseline (n= 201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremely Severe: Week 14 (n= 135)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint</title>
        <description>CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
        <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
        <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Double Blind (DB) Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: DB Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint</title>
          <description>CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
          <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.</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="64"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.88" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="2.9" spread="0.70" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at DB endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.91"/>
                    <measurement group_id="O2" value="1.1" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14</title>
        <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.</description>
        <time_frame>Baseline and Week 14</time_frame>
        <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Run-in or Stabilization Phase</title>
            <description>Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14</title>
          <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.</description>
          <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.</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="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6" spread="13.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14 (n=200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="17.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint</title>
        <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
        <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
        <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Double Blind (DB) Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: DB Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint</title>
          <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
          <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.</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="64"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3" spread="11.17" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="69.9" spread="9.37" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at DB Endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="12.87"/>
                    <measurement group_id="O2" value="-10.7" spread="14.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14</title>
        <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;).</description>
        <time_frame>Baseline and Week 14</time_frame>
        <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Run-in or Stabilization Phase</title>
            <description>Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14</title>
          <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;).</description>
          <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.</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="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.4" spread="24.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14 (n=192)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="29.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint</title>
        <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
        <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
        <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Double Blind (DB) Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: DB Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint</title>
          <description>Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
          <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point.</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="64"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 64, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5" spread="20.45" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="81.9" spread="14.82" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at DB Endpoint (n= 60, 69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="20.02"/>
                    <measurement group_id="O2" value="-22.4" spread="27.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14</title>
        <description>Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;).</description>
        <time_frame>Baseline and Week 14</time_frame>
        <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Run-in or Stabilization Phase</title>
            <description>Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14</title>
          <description>Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;).</description>
          <population>The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.</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="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" spread="27.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 14 (n=192)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.3" spread="33.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint</title>
        <description>Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
        <time_frame>DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])</time_frame>
        <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Double Blind (DB) Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: DB Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint</title>
          <description>Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: &quot;very badly&quot; to 100: &quot;very well&quot;). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).</description>
          <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. &quot;n&quot; signifies those participants who were evaluated for this measure at the specified time point.</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="64"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 64, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="24.24" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="24.4" spread="22.93" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at DB Endpoint (n= 60, 69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="23.18"/>
                    <measurement group_id="O2" value="1.2" spread="28.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)</title>
        <description>A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).</description>
        <time_frame>DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)</time_frame>
        <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone: Double Blind (DB) Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
          </group>
          <group group_id="O2">
            <title>Placebo: DB Phase</title>
            <description>Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)</title>
          <description>A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).</description>
          <population>The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.</measurement>
                    <measurement group_id="O2" value="52.0" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint</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. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
        <time_frame>OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)</time_frame>
        <population>The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone DB/Paliperidone Open-label (OL) Extension Phase</title>
            <description>Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo DB/Paliperidone OL Extension Phase</title>
            <description>Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint</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. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
          <population>The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. &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="46"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.5" spread="14.86" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="67.2" spread="14.67" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at OLE endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="11.30"/>
                    <measurement group_id="O2" value="-15.4" spread="12.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint</title>
        <description>CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
        <time_frame>OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)</time_frame>
        <population>The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone DB/Paliperidone Open-label (OL) Extension Phase</title>
            <description>Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo DB/Paliperidone OL Extension Phase</title>
            <description>Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint</title>
          <description>CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
          <population>The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. &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="46"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.02" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="3.9" spread="0.98" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at OLE endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.78"/>
                    <measurement group_id="O2" value="-0.9" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint</title>
        <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
        <time_frame>OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)</time_frame>
        <population>The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. &quot;N&quot; (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Paliperidone DB/Paliperidone Open-label (OL) Extension Phase</title>
            <description>Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo DB/Paliperidone OL Extension Phase</title>
            <description>Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint</title>
          <description>The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).</description>
          <population>The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. &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="46"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.8" spread="15.68" lower_limit="9." upper_limit="NA"/>
                    <measurement group_id="O2" value="60.6" spread="15.63" lower_limit="29.0" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at OLE endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.88" spread="3.1"/>
                    <measurement group_id="O2" value="10.7" spread="14.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Paliperidone: Run-in or Stabilization Phase</title>
          <description>Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.</description>
        </group>
        <group group_id="E2">
          <title>Paliperidone: Double Blind (DB) Phase</title>
          <description>Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.</description>
        </group>
        <group group_id="E3">
          <title>Placebo: DB Phase</title>
          <description>Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.</description>
        </group>
        <group group_id="E4">
          <title>Paliperidone DB/Paliperidone Open-label (OL) Extension Phase</title>
          <description>Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
        </group>
        <group group_id="E5">
          <title>Placebo DB/Paliperidone OL Extension Phase</title>
          <description>Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 15.1</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="2" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Completed Suicide</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hallucination, Auditory</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Psychotic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 15.1</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="141" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="14" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypertonia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="201"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="59"/>
              </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>If an Investigator wishes to publish information from study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. If requested by the Sponsor, investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application. Investigators will not publish data derived from individual site until Sponsor confirms there will be no multi-center study publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Independent Data Monitoring Committee (IDMC) conducted an interim analysis after 61st relapse in double-blind (DB) phase and DB phase completed on 09-Nov-2012 based on positive results of interim analysis.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Director Clinical Leader</name_or_title>
      <organization>Johnson &amp; Johnson Pharmaceutical Research &amp; Development, L.L.C.</organization>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </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/NCT01662310
org study id: CR100427
secondary id: R076477-SCH-3041
nct id: NCT01662310
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy, tolerability and safety of
      paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in
      the prevention of relapse in schizophrenia participants.
This is a double-blind (neither physician nor participant knows the name of the assigned
      drug), randomized (participants are assigned to treatment by a chance), placebo-controlled,
      and parallel-group study of paliperidone ER tablets. The study will consist of 6 phases: 14
      days of screening phase, 8 weeks of open-label run-in phase (participants will be flexibly
      dosed with paliperidone ER once daily in a dose range of 3 mg to 12 mg), 6 weeks of
      stabilization phase (participants will continue to receive the fixed dose of paliperidone
      ER), double-blind (DB) phase of various length (participants will be randomly assigned in a
      1:1 ratio to receive either paliperidone ER or placebo and this phase will be completed after
      86 relapse events are observed or if the study is positive at the interim analysis), 6 months
      of open-label extension (participants who experience a relapse event or who remain relapse
      free for the entire duration of the double-blind phase and participants who are enrolled at
      the time the study is terminated, will be eligible for this phase. All participants will be
      treated with paliperidone ER and safety and tolerability information will be collected during
      this phase) phase and 6 months of follow-up phase (participants who withdraw during the DB
      phase for any reason other than relapse will be followed for 6 months or until they
      experience a relapse). Participants' safety will be monitored throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Double Blind (DB) Phase: Median Time to Relapse
time frame: DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)
description: A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.
measure: Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14
time frame: Baseline and Week 14
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.
measure: Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint
time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
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. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
measure: Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
time frame: Baseline and Week 14
description: The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
measure: Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint
time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
description: CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
measure: Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14
time frame: Baseline and Week 14
description: The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.
measure: Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint
time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
description: The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
measure: Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14
time frame: Baseline and Week 14
description: Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well").
measure: Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint
time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
description: Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
measure: Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14
time frame: Baseline and Week 14
description: Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well").
measure: Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint
time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
description: Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
measure: Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)
time frame: DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)
description: A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).
measure: Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint
time frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
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. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
measure: Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint
time frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
description: CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
measure: Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint
time frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
description: The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
arm group label: Paliperidone: Run-in or Stabilization phase
arm group type: Experimental
description: Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose will be increased from milligram per day (3 mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
arm group label: Paliperidone: Double blind (DB) phase
arm group type: Experimental
description: Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg.
arm group label: Placebo: DB phase
arm group type: Active Comparator
description: Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg.
intervention type: Drug
intervention name: Paliperidone
description: Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day.
arm group label: Paliperidone: Double blind (DB) phase
arm group label: Paliperidone: Run-in or Stabilization phase
other name: R076477
intervention type: Drug
intervention name: Placebo
description: Participants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study.
arm group label: Placebo: DB phase
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
facility: 
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facility: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Paliperidone Palmitate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Independent Data Monitoring Committee (IDMC) conducted an interim analysis after 61st relapse in double-blind (DB) phase and DB phase completed on 09-Nov-2012 based on positive results of interim analysis.
point of contact: 