<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/NCT03009448</url>
  </required_header>
  <id_info>
    <org_study_id>shalvataMHC</org_study_id>
    <nct_id>NCT03009448</nct_id>
  </id_info>
  <brief_title>The Experience of Older Adults Facing Depression for the First Time in Old Age</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shalvata Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shalvata Mental Health Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Analysis of recent studies show that researchers find it hard to distinguish between Late&#xD;
      Onset Depression, a first diagnosed major depressive episode which occurs at old age, and&#xD;
      Early Onset Depression, a depressive episode at old age with a history of previous episodes.&#xD;
      Since current data, about the phenomenology and etiology of Late Onset Depression, lake&#xD;
      conicity it is unclear whether this phenomena should be considered as a distinct subtype of&#xD;
      depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a&#xD;
      stronger correlation with brain damage and environmental risk factors such as the common&#xD;
      losses at old age and weaker correlation with family history and genetics when compared to&#xD;
      Early Onset. Although many researchers consider brain damage to have the main contribution to&#xD;
      the emerge of Late Onset Depression, the fact that depression has a negative effect on one's&#xD;
      health supports the claim that it might be the result and not the rick factor. Since Late&#xD;
      Onset Depression correlates with the common losses at old age, the investigators propose that&#xD;
      an existential approach that deals with one's meaning, freedom, responsibly and death, might&#xD;
      be more appropriate. Thus, the investigators ask how do older adults experience depression&#xD;
      which they face for the first time in old age? Current study will seek to understand older&#xD;
      adults' experience of Late Onset depression through existential paradigm by using a semi&#xD;
      constructed interview.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2017</start_date>
  <primary_completion_date type="Anticipated">October 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Data analysis</measure>
    <time_frame>10 weeks</time_frame>
    <description>All the data collected, from each semi structured interview, will be analyzed by the investigator to find similarities or differences between the older adults' experience and to identify specific existential themes.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15</enrollment>
  <condition>MAjor Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Late onset depression</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Each subject will be interviewed using a semi constructed interview.</description>
    <arm_group_label>Late onset depression</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Israeli men and women after the age of retirement, 67 and 62 respectably, who are diagnosed&#xD;
        with a major depressive episode, minor depressive episode or show depressive symptoms for&#xD;
        the first time in their lives at old age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men aged 67 or more, women aged 62 or more&#xD;
&#xD;
          2. Diagnosis of Major Depressive Disorder, Minor Depressive Disorder or Adjustment&#xD;
             Disorder with depressive features made after the age of 67 with men and 62 with women.&#xD;
&#xD;
          3. Basic understanding and ability to converse in Hebrew.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of at least one previous major depressive or minor depressive episode before&#xD;
             the age of 62 with women or 67 with men&#xD;
&#xD;
          2. Mental Retardation or Autistic Spectrum Disorder&#xD;
&#xD;
          3. Significant cognitive impairment observed by the primary physician.&#xD;
&#xD;
          4. Schizophrenia or Schizoaffective disorder.&#xD;
&#xD;
          5. Depressive episode with psychotic features&#xD;
&#xD;
          6. Substantial suicidality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>62 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shalvata MHC</name>
      <address>
        <city>Hod HaSharon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 31, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 31, 2016</last_update_submitted>
  <last_update_submitted_qc>December 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</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>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT03009448
org study id: shalvataMHC
nct id: NCT03009448
lead sponsor: 
has dmc: Yes
Analysis of recent studies show that researchers find it hard to distinguish between Late
      Onset Depression, a first diagnosed major depressive episode which occurs at old age, and
      Early Onset Depression, a depressive episode at old age with a history of previous episodes.
      Since current data, about the phenomenology and etiology of Late Onset Depression, lake
      conicity it is unclear whether this phenomena should be considered as a distinct subtype of
      depression. Nevertheless, the wide spread assumption is that Late Onset Depression has a
      stronger correlation with brain damage and environmental risk factors such as the common
      losses at old age and weaker correlation with family history and genetics when compared to
      Early Onset. Although many researchers consider brain damage to have the main contribution to
      the emerge of Late Onset Depression, the fact that depression has a negative effect on one's
      health supports the claim that it might be the result and not the rick factor. Since Late
      Onset Depression correlates with the common losses at old age, the investigators propose that
      an existential approach that deals with one's meaning, freedom, responsibly and death, might
      be more appropriate. Thus, the investigators ask how do older adults experience depression
      which they face for the first time in old age? Current study will seek to understand older
      adults' experience of Late Onset depression through existential paradigm by using a semi
      constructed interview.
observational model: Case-Only
time perspective: Retrospective
measure: Data analysis
time frame: 10 weeks
description: All the data collected, from each semi structured interview, will be analyzed by the investigator to find similarities or differences between the older adults' experience and to identify specific existential themes.
arm group label: Late onset depression
intervention type: Other
intervention name: Interview
description: Each subject will be interviewed using a semi constructed interview.
arm group label: Late onset depression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 62 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major