<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/NCT04404309</url>
  </required_header>
  <id_info>
    <org_study_id>EA2/061/20</org_study_id>
    <nct_id>NCT04404309</nct_id>
  </id_info>
  <brief_title>Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)</brief_title>
  <acronym>OASIS-D</acronym>
  <official_title>Patient Characteristics, Validity of Clinical Diagnoses and Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen-Cilag G.m.b.H</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This 6-month, naturalistic cohort study examines male and female inpatients aged 18 to 75&#xD;
      years i) with any form of unipolar depressive episode (cohort 1); ii) clinical diagnosis of a&#xD;
      moderate or severe unipolar depressive episode and suicidal tendencies who agree to&#xD;
      participate in a prospective study (cohort 2); and moderate or severe unipolar depressive&#xD;
      episodes validated by research interviews and and suicidal tendencies that persist for at&#xD;
      least 48 hours after admission who are followed up for 6 months (cohort 3).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemiological cross-sectional study in over 3000 inpatients with a clinical diagnosis of&#xD;
      major depressive disorder, validation of the clinical diagnosis in 520 patients, and&#xD;
      prospective naturalistic 6-month follow-up study of 260 adults with a research&#xD;
      interview-confirmed major depressive disorder, with data collection at the following points:&#xD;
      at T0 = time of hospitalization (epidemiological study population 1 with data from clinical&#xD;
      routine practice), at time T1 of baseline survey in patients with persistent suicidal&#xD;
      tendencies, i.e. at least 48 hours after T0 (study population 2 as a subgroup of study&#xD;
      population 1, with study information and consent), and in study population 3 (subgroup of&#xD;
      study population 2, with study information and consent) at the time of discharge (T2), 3&#xD;
      months after admission to hospital (T3/ by telephone) and 6 months after inpatient admission&#xD;
      (T4).&#xD;
&#xD;
      The aim of the study is to characterize the remission or recurrence of suicidal symptoms in&#xD;
      the context of a depressive episode. It is expected that the results will help to improve the&#xD;
      understanding of the disease process and the further development of effective intervention&#xD;
      options.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sheehan Suicidality Tracking Scale (S-STS)</measure>
    <time_frame>20 min</time_frame>
    <description>Interview for Suicidality, Suicidal Behavior and Suicide Attempts, the higher the value the worse the outcome, the values can range from 0- 156</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini-International Neuropsychiatric Interview (M.I.N.I.)</measure>
    <time_frame>40 min</time_frame>
    <description>Semi-structured interview for research diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Resolution Suicide Risk (CGI-SR-R)</measure>
    <time_frame>1 min</time_frame>
    <description>One Question rated by an interviewer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)</measure>
    <time_frame>1 min</time_frame>
    <description>One Question rated by an interviewer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Severity (CGI-S)</measure>
    <time_frame>1 min</time_frame>
    <description>One Question about severity of illness, rated by an interviewer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Change (CGI-C)</measure>
    <time_frame>1 min</time_frame>
    <description>One Question about change of the symptoms rated by an interviewer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Young Mania Rating Scale (YMRS)</measure>
    <time_frame>20 min</time_frame>
    <description>Structured Interview for Mania Symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montgomery-Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>20 min</time_frame>
    <description>Structured Interview for Symptoms of Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service Use and Resource Form (SURF)</measure>
    <time_frame>30 min</time_frame>
    <description>Structured Interview for Service Use of the health care system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence Questions</measure>
    <time_frame>5 min</time_frame>
    <description>Semi Structured Interview for Adherence of Antipsychotics</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">3331</enrollment>
  <condition>Depression</condition>
  <condition>Depression Moderate</condition>
  <condition>Depression Severe</condition>
  <condition>Suicidal and Self-injurious Behavior</condition>
  <condition>Suicidal Ideation</condition>
  <condition>Suicide, Attempted</condition>
  <arm_group>
    <arm_group_label>Population 1</arm_group_label>
    <description>Any patient admitted to a psychiatric ward with a clinical diagnosis of (unipolar) major depression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population 2</arm_group_label>
    <description>Any patient with a clinical diagnosis of a moderate or severe unipolar depressive disorder with suicidal tendencies that persist for at least 48 hours after admission</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population 3</arm_group_label>
    <description>Patients with moderate or severe unipolar depressive episodes validated by research interviews and suicidal tendencies that persist for at least 48 hours after admission who will be followed up for 6 months</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patient are gonna be recruited from 7 different psychiatric clinics. For population 1,&#xD;
        only clinically available data is extracted from patient records population 2 and 3:&#xD;
        Patients who meet the inclusion criteria and are in psychiatric hospital treatment in the&#xD;
        study centres&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Population 1&#xD;
&#xD;
        1.any form of unipolar depressive episode&#xD;
&#xD;
        For Population 2&#xD;
&#xD;
          1. clinical diagnosis of a moderate or severe unipolar depressive episode&#xD;
&#xD;
          2. clinically diagnosed suicidal tendencies that persist for at least 48 hours after&#xD;
             admission to hospital&#xD;
&#xD;
          3. Written consent to participate in the study&#xD;
&#xD;
        For Population 3&#xD;
&#xD;
          1. Diagnosis of a moderate or severe unipolar depressive disorder through the structured&#xD;
             research interview &quot;Mini International Neuropsychiatric Interview&quot; (M.I.N.I.)&#xD;
&#xD;
          2. Suicidality with a value &gt; / = 1 for item 2 (passive suicidality) OR item 3 (active&#xD;
             suicidality) based on the research interview &quot;Sheehan Suicidality Tracking Scale&quot;&#xD;
             (S-STS)&#xD;
&#xD;
          3. Written consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years or older than 75 years&#xD;
&#xD;
          -  No clinical diagnosis of a depressive episode&#xD;
&#xD;
          -  Depressive episode in the context of a bipolar disorder- secondary depression as a&#xD;
             result of physical illness or substance use&#xD;
&#xD;
          -  severe physical symptoms of disease that make participation in the study impossible&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  not being able to understand the study processes&#xD;
&#xD;
          -  incapable of giving informed consent&#xD;
&#xD;
          -  no authorization to give consent due to (limited) incapacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph U Correll, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christoph U Correll, MD</last_name>
    <phone>+49-30-450</phone>
    <phone_ext>566202</phone_ext>
    <email>christoph.correll@charite.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Charité</name>
      <address>
        <city>Berlin-Mitte</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabiola Heuer</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Prof. Dr. med Christoph Correll</investigator_full_name>
    <investigator_title>Clinic Director</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Suicidality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Suicide, Attempted</mesh_term>
    <mesh_term>Self-Injurious Behavior</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/NCT04404309
org study id: EA2/061/20
nct id: NCT04404309
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This 6-month, naturalistic cohort study examines male and female inpatients aged 18 to 75
      years i) with any form of unipolar depressive episode (cohort 1); ii) clinical diagnosis of a
      moderate or severe unipolar depressive episode and suicidal tendencies who agree to
      participate in a prospective study (cohort 2); and moderate or severe unipolar depressive
      episodes validated by research interviews and and suicidal tendencies that persist for at
      least 48 hours after admission who are followed up for 6 months (cohort 3).
Epidemiological cross-sectional study in over 3000 inpatients with a clinical diagnosis of
      major depressive disorder, validation of the clinical diagnosis in 520 patients, and
      prospective naturalistic 6-month follow-up study of 260 adults with a research
      interview-confirmed major depressive disorder, with data collection at the following points:
      at T0 = time of hospitalization (epidemiological study population 1 with data from clinical
      routine practice), at time T1 of baseline survey in patients with persistent suicidal
      tendencies, i.e. at least 48 hours after T0 (study population 2 as a subgroup of study
      population 1, with study information and consent), and in study population 3 (subgroup of
      study population 2, with study information and consent) at the time of discharge (T2), 3
      months after admission to hospital (T3/ by telephone) and 6 months after inpatient admission
      (T4).

      The aim of the study is to characterize the remission or recurrence of suicidal symptoms in
      the context of a depressive episode. It is expected that the results will help to improve the
      understanding of the disease process and the further development of effective intervention
      options.
observational model: Cohort
time perspective: Prospective
measure: Sheehan Suicidality Tracking Scale (S-STS)
time frame: 20 min
description: Interview for Suicidality, Suicidal Behavior and Suicide Attempts, the higher the value the worse the outcome, the values can range from 0- 156
measure: Mini-International Neuropsychiatric Interview (M.I.N.I.)
time frame: 40 min
description: Semi-structured interview for research diagnosis
measure: Clinical Global Impression of Resolution Suicide Risk (CGI-SR-R)
time frame: 1 min
description: One Question rated by an interviewer
measure: Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
time frame: 1 min
description: One Question rated by an interviewer
measure: Clinical Global Impression - Severity (CGI-S)
time frame: 1 min
description: One Question about severity of illness, rated by an interviewer
measure: Clinical Global Impression - Change (CGI-C)
time frame: 1 min
description: One Question about change of the symptoms rated by an interviewer
measure: Young Mania Rating Scale (YMRS)
time frame: 20 min
description: Structured Interview for Mania Symptoms
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
time frame: 20 min
description: Structured Interview for Symptoms of Depression
measure: Service Use and Resource Form (SURF)
time frame: 30 min
description: Structured Interview for Service Use of the health care system
measure: Adherence Questions
time frame: 5 min
description: Semi Structured Interview for Adherence of Antipsychotics
arm group label: Population 1
description: Any patient admitted to a psychiatric ward with a clinical diagnosis of (unipolar) major depression
arm group label: Population 2
description: Any patient with a clinical diagnosis of a moderate or severe unipolar depressive disorder with suicidal tendencies that persist for at least 48 hours after admission
arm group label: Population 3
description: Patients with moderate or severe unipolar depressive episodes validated by research interviews and suicidal tendencies that persist for at least 48 hours after admission who will be followed up for 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Christoph U Correll, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
last name: Christoph U Correll, MD
phone: +49-30-450
phone ext: 566202
email: christoph.correll@charite.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Prof. Dr. med Christoph Correll
investigator title: Clinic Director
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Suicide
mesh term: Suicidal Ideation
mesh term: Suicide, Attempted
mesh term: Self-Injurious Behavior