<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/NCT03809325</url>
  </required_header>
  <id_info>
    <org_study_id>CR108568</org_study_id>
    <secondary_id>R092670SCH4066</secondary_id>
    <nct_id>NCT03809325</nct_id>
  </id_info>
  <brief_title>A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly</brief_title>
  <official_title>Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the experience with paliperidone palmitate 3-month&#xD;
      formulation (PP3M) treatment of participants and their corresponding physicians, nurses and&#xD;
      carers, to understand the impact of less frequent injections from their perspective.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Actual">July 12, 2019</completion_date>
  <primary_completion_date type="Actual">July 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Participant's Experience with PP3M Treatment</measure>
    <time_frame>1 day</time_frame>
    <description>Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responses to the Questionnaires</measure>
    <time_frame>1 day</time_frame>
    <description>The response to the questionnaires of the corresponding physician, and the corresponding nurse and carer where applicable, for each participant will be collected for the following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression-Severity (CGI-S) Score</measure>
    <time_frame>1 day</time_frame>
    <description>The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)</measure>
    <time_frame>1 day</time_frame>
    <description>The PANSS is a validated scale specific for the measurement of the symptoms of schizophrenia. The neuropsychiatric symptoms of schizophrenia are assessed across 3 subscales comprising a total of 30 items; the positive [P] and negative [N] subscales each includes 7 items, while the general psychopathology [G] subscale includes 16 items. Lack of judgment and insight's score is 12th item of the general psychopathology subscale (G12 item) of PANSS with score ranges from 1 to 7. Higher scores indicate worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score</measure>
    <time_frame>1 day</time_frame>
    <description>EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating &quot;health today&quot; with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (worst health state) to 1 (better health state) representing the general health status of the individual.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">225</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Participants with Schizophrenia</arm_group_label>
    <description>No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paliperidone Palmitate 3-Month Formulation (PP3M)</intervention_name>
    <description>No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.</description>
    <arm_group_label>Participants with Schizophrenia</arm_group_label>
    <other_name>Trevicta</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants diagnosed with schizophrenia who are currently receiving paliperidone&#xD;
        palmitate 3-month formulation (PP3M) and have previously received 4 to 6 injections of PP3M&#xD;
        treatment will be enrolled. Feedback will be collected using an online questionnaire-based&#xD;
        tool at a single data collection time point.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of schizophrenia (according to International Classification of&#xD;
             Diseases [ICD]-10)&#xD;
&#xD;
          -  Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M&#xD;
&#xD;
          -  Have the required language skills to participate in the online questionnaire, in the&#xD;
             opinion of the physician&#xD;
&#xD;
          -  Be able and willing to provide their informed consent for study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received involuntary treatment with PP3M&#xD;
&#xD;
          -  Was switched to PP3M treatment within a clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Brugmann</name>
      <address>
        <city>Bruxelles</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Médico Psychologique De Courbevoie</name>
      <address>
        <city>Asnieres Sur Seine</city>
        <zip>92600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Medico Psychologique</name>
      <address>
        <city>Cagnes Sur Mer</city>
        <zip>6800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet medical</name>
      <address>
        <city>Dax</city>
        <zip>40100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Esquirol</name>
      <address>
        <city>Limoges</city>
        <zip>87025</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Jury</name>
      <address>
        <city>Metz Cedex 3</city>
        <zip>57073</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Montauban</name>
      <address>
        <city>Montauban</city>
        <zip>82013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Colombière</name>
      <address>
        <city>Montpellier</city>
        <zip>34090</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Medico Psychologique Le Rembrandt</name>
      <address>
        <city>Nice</city>
        <zip>6300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Novillars</name>
      <address>
        <city>Novillars</city>
        <zip>25220</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Guillaume Regnier</name>
      <address>
        <city>Rennes Cedex 7</city>
        <zip>35703</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Sainte Musse</name>
      <address>
        <city>Toulon</city>
        <zip>83100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum Am Urban</name>
      <address>
        <city>Berlin</city>
        <zip>10967</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NPZR - Neuropsychatrisches Zentrum Riem</name>
      <address>
        <city>Muenchen</city>
        <zip>81829</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kbo-Inn-Salzach-Klinikum GmbH</name>
      <address>
        <city>Wasserburg A. Inn</city>
        <zip>83512</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toldy Ferenc Kórház-Rendelőintézet</name>
      <address>
        <city>Cegléd</city>
        <zip>2700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet</name>
      <address>
        <city>Celldömölk</city>
        <zip>9500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sántha Kálmán Szakkórház</name>
      <address>
        <city>Nagykálló</city>
        <zip>4320</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tolna Megyei Balassa János Kórház</name>
      <address>
        <city>Szekszárd</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Alto Adige</name>
      <address>
        <city>Bolzano</city>
        <zip>39100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili</name>
      <address>
        <city>Brescia</city>
        <zip>25100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSM Frosinone</name>
      <address>
        <city>Frosinone</city>
        <zip>3100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa di Cura Villa Von Siebenthal</name>
      <address>
        <city>Genzano di Roma</city>
        <zip>100045</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Igiene Mentale ASL Salerno</name>
      <address>
        <city>Oliveto Citra</city>
        <zip>84020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPDC Asltaranto</name>
      <address>
        <city>Statte</city>
        <zip>74010</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Abente E Lago</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csm Miraflores</name>
      <address>
        <city>Alcobendas</city>
        <zip>28100</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csm Arganda Del Rey</name>
      <address>
        <city>Arganda</city>
        <zip>28500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Usmc Carmona</name>
      <address>
        <city>Carmona</city>
        <zip>41410</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Gral. Univ. Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Usmc Mairena Del Aljarafe</name>
      <address>
        <city>Mairena Del Aljarafe</city>
        <zip>41927</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hosp. de Manresa</name>
      <address>
        <city>Manresa</city>
        <zip>8243</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacio Sanitari Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <zip>8208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. de Torrevieja</name>
      <address>
        <city>Torrevieja</city>
        <zip>3188</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csm Rondilla</name>
      <address>
        <city>Valladolid</city>
        <zip>47010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Psiquiatrico Alava</name>
      <address>
        <city>Vitoria-Gasteiz</city>
        <zip>1006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham &amp; Solihull MH NHS FT</name>
      <address>
        <city>Birmingham</city>
        <zip>B18 5SD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Partnership NHS Trust</name>
      <address>
        <city>Leicester</city>
        <zip>LE2 0TA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West London Mental Health Trust</name>
      <address>
        <city>London</city>
        <zip>W3 8NJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Ireland</country>
  </removed_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paliperidone Palmitate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03809325
org study id: CR108568
secondary id: R092670SCH4066
nct id: NCT03809325
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the experience with paliperidone palmitate 3-month
      formulation (PP3M) treatment of participants and their corresponding physicians, nurses and
      carers, to understand the impact of less frequent injections from their perspective.
observational model: Cohort
time perspective: Cross-Sectional
measure: Participant's Experience with PP3M Treatment
time frame: 1 day
description: Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
measure: Responses to the Questionnaires
time frame: 1 day
description: The response to the questionnaires of the corresponding physician, and the corresponding nurse and carer where applicable, for each participant will be collected for the following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
measure: Clinical Global Impression-Severity (CGI-S) Score
time frame: 1 day
description: The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
measure: Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)
time frame: 1 day
description: The PANSS is a validated scale specific for the measurement of the symptoms of schizophrenia. The neuropsychiatric symptoms of schizophrenia are assessed across 3 subscales comprising a total of 30 items; the positive [P] and negative [N] subscales each includes 7 items, while the general psychopathology [G] subscale includes 16 items. Lack of judgment and insight's score is 12th item of the general psychopathology subscale (G12 item) of PANSS with score ranges from 1 to 7. Higher scores indicate worsening.
measure: European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score
time frame: 1 day
description: EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (worst health state) to 1 (better health state) representing the general health status of the individual.
arm group label: Participants with Schizophrenia
description: No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable.
intervention type: Drug
intervention name: Paliperidone Palmitate 3-Month Formulation (PP3M)
description: No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.
arm group label: Participants with Schizophrenia
other name: Trevicta
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
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country: Belgium
country: France
country: Germany
country: Hungary
country: Italy
country: Spain
country: United Kingdom
country: Ireland
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Paliperidone Palmitate
sharing ipd: No