<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/NCT01698216</url>
  </required_header>
  <id_info>
    <org_study_id>Consta_Sustenna</org_study_id>
    <nct_id>NCT01698216</nct_id>
  </id_info>
  <brief_title>Switching From Consta® to Sustenna® in Patients With Schizophrenia</brief_title>
  <official_title>Switching From Risperidone Long Acting Injection (Consta®) to Paliperidone Palmitate (Sustenna®) in Patients With Schizophrenia and Its Influence on Subjective Well-Being: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is observation of effectiveness and side effect of patients with&#xD;
      schizophrenia who will switch the antipsychotics from risperidone long acting injection to&#xD;
      paliperidone palmitate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, investigators are going to enroll the patients who will switch the risperidone&#xD;
      long acting injection to paliperidone palmitate. And investigators will examine the&#xD;
      effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side&#xD;
      effect related variables will be studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Well-being Under Neuroleptic Treatment (SWN)</measure>
    <time_frame>Change from Baseline in SWN score at 108 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Korean Drug Attitude Inventory-10</measure>
    <time_frame>Change from Baseline in score at 108 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Syndrome Scale</measure>
    <time_frame>0,4,8,16,24,36,48,60,72,84,96,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression-Severity, Improvement</measure>
    <time_frame>0,4,8,16,24,36,48,60,72,84,96,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal and Social Performance Scale</measure>
    <time_frame>0,4,8,16,24,36,48,60,72,84,96,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Check List-90-Revised</measure>
    <time_frame>0,4,8,16,24,36,48,60,72,84,96,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug-Induced ExtraPyramidal Symptoms Scale</measure>
    <time_frame>0,4,8,16,24,36,48,60,72,84,96,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liverpool University Neuroleptic Side Effect Rating Scale</measure>
    <time_frame>0,4,8,16,24,36,48,60,72,84,96,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>0,4,8,16,24,36,48,60,72,84,96,108 week</time_frame>
    <description>injection site pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECG</measure>
    <time_frame>8, 24, 48, 72, 108 week</time_frame>
    <description>electrocardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>0,4,8,16,24,48,72,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>0,4,8,16,24,48,72,108 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist circumference</measure>
    <time_frame>0,4,8,16,24,48,72,108 week</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Consta Sustenna switching</arm_group_label>
    <description>The patients group who switched to paliperidone palmitate from risperidone long acting injection</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with schizophrenia who would be switched to Paliperidone Palmitate from&#xD;
        Risperidone Long Acting Injection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 ~ 65&#xD;
&#xD;
          -  Patient with schizophrenia according to DSM-IV criteria&#xD;
&#xD;
          -  Patient have signed on the informed consent, and well understood the objective and&#xD;
             procedure of this study.&#xD;
&#xD;
          -  Maintenance therapy more than 6 months with Risperidone Long Acting Injection&#xD;
             monotherapy or other with concomitant antipsychotics, and stable dose of Risperidone&#xD;
             Long Acting Injection was maintained 8 weeks more. The stable dose of other&#xD;
             antipsychotics has been maintained 8 months and more.&#xD;
&#xD;
          -  Patient wants to switch antipsychotics to Paliperidone Palmitate.&#xD;
&#xD;
          -  PANSS total score ≤ 80&#xD;
&#xD;
          -  Each score of conceptual disorganization(P2), hallucinatory behavior(P3),&#xD;
             Suspiciousness/persecution(P6), unusual thought content(G9)in PANSS ≤ 4&#xD;
&#xD;
          -  Competent patient who is manage to answer the questionnaires.&#xD;
&#xD;
          -  In case of female at child-bearing age, consent to use appropriate contraceptive&#xD;
             methods(oral pill, contraceptive injection, intrauterine device, double barrier method&#xD;
             and contraceptive patch) during entire duration of this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No history of antipsychotics use.&#xD;
&#xD;
          -  Past history of NMS.&#xD;
&#xD;
          -  Allergy or hypersensitivity to Risperidone or Paliperidone ER.&#xD;
&#xD;
          -  Concomitant antipsychotics was oral Risperidone or Paliperidone ER.&#xD;
&#xD;
          -  Initiating or dose-changing of SSRI, MAOI, TCA within 2 months(maintenance is allowed&#xD;
             if those have been stable for at least 30days prior to study entry and would not be&#xD;
             any dose changes during the study)&#xD;
&#xD;
          -  Initiating of Lithium, Valproic acid, Carbamazepine, Topiramate, Lamotrigine or other&#xD;
             mood stabilizer within 2months (maintenance is allowed).&#xD;
&#xD;
          -  Patient who is supposed to be impossible to participate to this study due to clinical&#xD;
             risk of suicide or aggressive behavior based on clinician's opinion.&#xD;
&#xD;
          -  Current substance dependence(DSM-IV) or past history of dependence (more than 6months)&#xD;
&#xD;
          -  Significant biochemical or hematological abnormality or abnormal finding of&#xD;
             urinalysis, based on clinician's opinion.&#xD;
&#xD;
          -  History of cardiac disease which predispose to QT prolongation(sick sinus, complete AV&#xD;
             block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia) or current&#xD;
             medication of QT prolonging drugs&#xD;
&#xD;
          -  Pregnant or breast-feeding female patient.&#xD;
&#xD;
          -  History of participating to other investigational drug trial within 1month prior to&#xD;
             screening.&#xD;
&#xD;
          -  Investigator or employee at clinical trial center, personnel related to investigator&#xD;
             or trial center on this or other study, or family of employee or investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong Min Ahn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>December 7, 2015</last_update_submitted>
  <last_update_submitted_qc>December 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yong Min Ahn</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Paliperidone</keyword>
  <keyword>Palmitate</keyword>
  <keyword>switching</keyword>
  <keyword>schizophrenia</keyword>
  <keyword>subjective well-being</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698216
org study id: Consta_Sustenna
nct id: NCT01698216
lead sponsor: 
has dmc: Yes
The aim of this study is observation of effectiveness and side effect of patients with
      schizophrenia who will switch the antipsychotics from risperidone long acting injection to
      paliperidone palmitate.
In this study, investigators are going to enroll the patients who will switch the risperidone
      long acting injection to paliperidone palmitate. And investigators will examine the
      effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side
      effect related variables will be studied.
observational model: Case-Only
time perspective: Prospective
measure: Subjective Well-being Under Neuroleptic Treatment (SWN)
time frame: Change from Baseline in SWN score at 108 weeks
measure: Korean Drug Attitude Inventory-10
time frame: Change from Baseline in score at 108 weeks
measure: Positive and Negative Syndrome Scale
time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Clinical Global Impression-Severity, Improvement
time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Personal and Social Performance Scale
time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Symptom Check List-90-Revised
time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Drug-Induced ExtraPyramidal Symptoms Scale
time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Liverpool University Neuroleptic Side Effect Rating Scale
time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
measure: Visual Analog Scale
time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
description: injection site pain
measure: ECG
time frame: 8, 24, 48, 72, 108 week
description: electrocardiogram
measure: blood pressure
time frame: 0,4,8,16,24,48,72,108 week
measure: Body weight
time frame: 0,4,8,16,24,48,72,108 week
measure: waist circumference
time frame: 0,4,8,16,24,48,72,108 week
arm group label: Consta Sustenna switching
description: The patients group who switched to paliperidone palmitate from risperidone long acting injection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yong Min Ahn, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yong Min Ahn
investigator title: professor
mesh term: Schizophrenia