<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/NCT01726335</url>
  </required_header>
  <id_info>
    <org_study_id>CR012484</org_study_id>
    <secondary_id>RISSCH4135</secondary_id>
    <nct_id>NCT01726335</nct_id>
  </id_info>
  <brief_title>Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia</brief_title>
  <official_title>An Open-Label Study of Oral Antipsychotics Replacement by Prolonged Release Risperidone (Risperdal Consta) in Schizophrenic Subjects With Bad Adhesion to the Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting&#xD;
      risperidone when switching from oral antipsychotics in participants with schizophrenia&#xD;
      (psychiatric disorder with symptoms of emotional instability, detachment from reality, often&#xD;
      with delusions and hallucinations, and withdrawal into the self).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), multi-centric&#xD;
      (conducted in more than one center) and non-comparative study of long-acting risperidone in&#xD;
      participants with schizophrenia who have a previous history (in the last 12 months) of bad&#xD;
      adherence to the oral antipsychotic treatment of first or second generation. The duration of&#xD;
      this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2,&#xD;
      4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible&#xD;
      participants (after risperidone intolerance test during screening) will receive a dose of 25&#xD;
      milligram risperidone every two weeks by intramuscular injection (injection of a substance&#xD;
      into a muscle). Efficacy and safety of the participants will primarily be evaluated by&#xD;
      Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively.&#xD;
      Participants' safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2006</start_date>
  <completion_date type="Actual">March 2008</completion_date>
  <primary_completion_date type="Actual">March 2008</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2</measure>
    <time_frame>Week 2</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>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4</measure>
    <time_frame>Week 4</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>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8</measure>
    <time_frame>Week 8</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>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16</measure>
    <time_frame>Week 16</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>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24</measure>
    <time_frame>Week 24</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>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38</measure>
    <time_frame>Week 38</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>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50</measure>
    <time_frame>Week 50</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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions (CGI) - Disease Severity Score</measure>
    <time_frame>Baseline and Week 2, 4, 8, 16, 24, 38 and 50</time_frame>
    <description>The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to &quot;normal, not at all ill&quot; and a rating of 7 indicates &quot;among the most extremely ill participants&quot;. Higher scores indicate worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extrapyramidal Symptoms Rating Scale (ESRS) Total Score</measure>
    <time_frame>Baseline and Week 2, 4, 8, 16, 24 and 50</time_frame>
    <description>The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Attitude Inventory (DAI-10)</measure>
    <time_frame>Screening, and Week 8, 24 and 50</time_frame>
    <description>The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36) - Quality of Life</measure>
    <time_frame>Baseline and Week 50</time_frame>
    <description>The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal and Social Performance (PSP) Scale Score</measure>
    <time_frame>Screening, and Week 8, 16, 24, 38 and 50</time_frame>
    <description>The PSP scale assesses the degree of a participant's dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Functioning (GAF) Scale Score</measure>
    <time_frame>Screening, and Week 8, 16, 24, 38 and 50</time_frame>
    <description>The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Risperidone prolonged release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone prolonged release</intervention_name>
    <description>Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.</description>
    <arm_group_label>Risperidone prolonged release</arm_group_label>
    <other_name>- Risperdal consta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders,&#xD;
             fourth edition (DSM-IV)&#xD;
&#xD;
          -  Be on treatment with oral antipsychotic of first or second generation, for a minimum&#xD;
             time of 12 months&#xD;
&#xD;
          -  Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months&#xD;
&#xD;
          -  Total Positive and Negative Syndrome Scale score less than or equal to 90, the&#xD;
             conceptual disorganization, hallucinatory behavior, suspicion and not usual content of&#xD;
             thought must be less than or equal to 4&#xD;
&#xD;
          -  Be not pregnant as showed on negative pregnancy serum test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication or known hypersensitivity to risperidone&#xD;
&#xD;
          -  Previous history of unsatisfactory response to risperidone&#xD;
&#xD;
          -  Previous history of refractivity to the other second generation antipsychotics&#xD;
&#xD;
          -  Use of antipsychotic of intramuscular deposit in the last 12 months&#xD;
&#xD;
          -  Other mental disturbances of DSM-IV axis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag Ltd. Clinical trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Curitiba</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rio De Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salvador</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <results_first_submitted>April 18, 2013</results_first_submitted>
  <results_first_submitted_qc>July 23, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 24, 2013</results_first_posted>
  <last_update_submitted>April 10, 2014</last_update_submitted>
  <last_update_submitted_qc>April 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Risperidone</keyword>
  <keyword>Risperdal consta</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>Risperidone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Risperidone Prolonged Release</title>
          <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Exacerbation of psychotic symptoms</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Risperidone Prolonged Release</title>
          <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
          </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="33.6" spread="9.1"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score</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>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.80" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2</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>Week 2</time_frame>
        <population>Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2</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>Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.53" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4</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>Week 4</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4</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 ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.82" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8</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>Week 8</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8</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 ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.28" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16</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>Week 16</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16</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 ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.55" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24</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>Week 24</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24</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 ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.95" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impressions (CGI) - Disease Severity Score</title>
        <description>The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to &quot;normal, not at all ill&quot; and a rating of 7 indicates &quot;among the most extremely ill participants&quot;. Higher scores indicate worsening.</description>
        <time_frame>Baseline and Week 2, 4, 8, 16, 24, 38 and 50</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impressions (CGI) - Disease Severity Score</title>
          <description>The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to &quot;normal, not at all ill&quot; and a rating of 7 indicates &quot;among the most extremely ill participants&quot;. Higher scores indicate worsening.</description>
          <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.55" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.30" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.21" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.10" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.92" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.94" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.19" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Extrapyramidal Symptoms Rating Scale (ESRS) Total Score</title>
        <description>The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).</description>
        <time_frame>Baseline and Week 2, 4, 8, 16, 24 and 50</time_frame>
        <population>Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Extrapyramidal Symptoms Rating Scale (ESRS) Total Score</title>
          <description>The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).</description>
          <population>Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.460" spread="0.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.416" spread="0.072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.272" spread="0.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.289" spread="0.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.271" spread="0.079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.221" spread="0.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.089" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Drug Attitude Inventory (DAI-10)</title>
        <description>The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).</description>
        <time_frame>Screening, and Week 8, 24 and 50</time_frame>
        <population>ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Drug Attitude Inventory (DAI-10)</title>
          <description>The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).</description>
          <population>ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.45" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.59" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.07" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form-36 (SF-36) - Quality of Life</title>
        <description>The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.</description>
        <time_frame>Baseline and Week 50</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form-36 (SF-36) - Quality of Life</title>
          <description>The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.</description>
          <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</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="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Functional capacity : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" spread="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical aspect : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" spread="40.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.7" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health General State : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Aspect : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.1" spread="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Aspect : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9" spread="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health : Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.9" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional capacity : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.9" spread="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical aspect : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.9" spread="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.4" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health General State : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.7" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Aspect : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.9" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Aspect : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0" spread="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health : Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38</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>Week 38</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38</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 ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.40" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50</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>Week 50</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50</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 ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.72" spread="2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Personal and Social Performance (PSP) Scale Score</title>
        <description>The PSP scale assesses the degree of a participant's dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.</description>
        <time_frame>Screening, and Week 8, 16, 24, 38 and 50</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Personal and Social Performance (PSP) Scale Score</title>
          <description>The PSP scale assesses the degree of a participant's dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.</description>
          <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.4" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.7" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.8" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Assessment of Functioning (GAF) Scale Score</title>
        <description>The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.</description>
        <time_frame>Screening, and Week 8, 16, 24, 38 and 50</time_frame>
        <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Risperidone Prolonged Release</title>
            <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Assessment of Functioning (GAF) Scale Score</title>
          <description>The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.</description>
          <population>The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.6" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.5" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 50</time_frame>
      <desc>Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.</desc>
      <group_list>
        <group group_id="E1">
          <title>Risperidone Prolonged Release</title>
          <description>Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Psychomotor hyperactivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperprolactinaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Feeling jittery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood prolactin increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Extrapyramidal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal behaviour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Apathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fear</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hostility</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Orgasm abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Schizophrenia, disorganised type</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Galactorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the Principal Investigator is that the Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the Sponsor for review. The Sponsor can require changes to the communication and can extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Group Manager</name_or_title>
      <organization>Janssen-Cilag Ltd.</organization>
      <phone>+55 11 30302738</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726335
org study id: CR012484
secondary id: RISSCH4135
nct id: NCT01726335
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting
      risperidone when switching from oral antipsychotics in participants with schizophrenia
      (psychiatric disorder with symptoms of emotional instability, detachment from reality, often
      with delusions and hallucinations, and withdrawal into the self).
This is an open-label (all people know the identity of the intervention), multi-centric
      (conducted in more than one center) and non-comparative study of long-acting risperidone in
      participants with schizophrenia who have a previous history (in the last 12 months) of bad
      adherence to the oral antipsychotic treatment of first or second generation. The duration of
      this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2,
      4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible
      participants (after risperidone intolerance test during screening) will receive a dose of 25
      milligram risperidone every two weeks by intramuscular injection (injection of a substance
      into a muscle). Efficacy and safety of the participants will primarily be evaluated by
      Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively.
      Participants' safety will be monitored throughout the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2
time frame: Week 2
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: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4
time frame: Week 4
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: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8
time frame: Week 8
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: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16
time frame: Week 16
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: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
time frame: Week 24
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: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38
time frame: Week 38
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: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50
time frame: Week 50
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: Clinical Global Impressions (CGI) - Disease Severity Score
time frame: Baseline and Week 2, 4, 8, 16, 24, 38 and 50
description: The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening.
measure: Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
time frame: Baseline and Week 2, 4, 8, 16, 24 and 50
description: The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).
measure: Drug Attitude Inventory (DAI-10)
time frame: Screening, and Week 8, 24 and 50
description: The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
measure: Short Form-36 (SF-36) - Quality of Life
time frame: Baseline and Week 50
description: The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.
measure: Personal and Social Performance (PSP) Scale Score
time frame: Screening, and Week 8, 16, 24, 38 and 50
description: The PSP scale assesses the degree of a participant's dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.
measure: Global Assessment of Functioning (GAF) Scale Score
time frame: Screening, and Week 8, 16, 24, 38 and 50
description: The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
arm group label: Risperidone prolonged release
arm group type: Experimental
description: Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.
intervention type: Drug
intervention name: Risperidone prolonged release
description: Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.
arm group label: Risperidone prolonged release
other name: - Risperdal consta
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Janssen-Cilag Ltd. Clinical trial
role: Study Director
affiliation: Janssen-Cilag Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Risperidone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 