<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/NCT01681407</url>
  </required_header>
  <id_info>
    <org_study_id>EMC-07411-CTIL</org_study_id>
    <nct_id>NCT01681407</nct_id>
  </id_info>
  <brief_title>Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications</brief_title>
  <acronym>MIRPROT</acronym>
  <official_title>Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in&#xD;
      depressive patients, treated with SSRI medications. It is an observational clinical&#xD;
      bio-markers laboratory controlled research with no device.&#xD;
&#xD;
      The research includes two groups; one for patients diagnosed of having depression, and will&#xD;
      get a standard SSRI medication regimen. Second group is for control subjects without&#xD;
      depression. An option for a third group is planned to include first degree relatives of the&#xD;
      depressed patients. After giving their informed consents, subjects and patients will go&#xD;
      through standard clinical psychiatric interview, and routine clinical lab tests. Clinical&#xD;
      standard, specific depression and anxiety questionnaires will be held at four follow-up&#xD;
      meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked&#xD;
      to give blood samples at these points of time for the lab processing: Complete plasma&#xD;
      proteomics and specific micro-RNA levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient microRNA for the analysis&#xD;
  </why_stopped>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive symptoms remission or response rates, under usual SSRI treatment.</measure>
    <time_frame>10 weeks of follow up</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Depressed Patients</arm_group_label>
    <description>Patients: Group of patients that are diagnosed for having depression, and are suitable for SSRI treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Depressed Controls</arm_group_label>
    <description>Controls: Volunteers that had clinical screening with no depression diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients Relatives</arm_group_label>
    <description>Patient Relatives (Optional group for later stage): First degree relatives with no depression diagnosis.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Subjects and patients will be asked to give blood samples at 4 points of time for the lab&#xD;
      processing: micro-RNA and proteome profiling/&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at community or hospital settings. Patients were clinically evaluated for&#xD;
        suspected depression.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Depressed patients,over 18 yo&#xD;
&#xD;
          -  Untreated with SSRI, in the last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bipolar patients or another major psychopathology&#xD;
&#xD;
          -  Depressive disorder clearly due to general medical condition, or drug related&#xD;
&#xD;
          -  BMI under 18.5 or above 40&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Active suicidality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HaEmek Medical Center</name>
      <address>
        <city>Afula</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>June 18, 2015</last_update_submitted>
  <last_update_submitted_qc>June 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Amichai Hareven</investigator_full_name>
    <investigator_title>Dr Amichai Hareven</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Selective Serotonin Reuptake Inhibitors</keyword>
  <keyword>MicroRNAs</keyword>
  <keyword>Proteome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT01681407
org study id: EMC-07411-CTIL
nct id: NCT01681407
lead sponsor: 
has dmc: Yes
A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in
      depressive patients, treated with SSRI medications. It is an observational clinical
      bio-markers laboratory controlled research with no device.

      The research includes two groups; one for patients diagnosed of having depression, and will
      get a standard SSRI medication regimen. Second group is for control subjects without
      depression. An option for a third group is planned to include first degree relatives of the
      depressed patients. After giving their informed consents, subjects and patients will go
      through standard clinical psychiatric interview, and routine clinical lab tests. Clinical
      standard, specific depression and anxiety questionnaires will be held at four follow-up
      meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked
      to give blood samples at these points of time for the lab processing: Complete plasma
      proteomics and specific micro-RNA levels.
observational model: Case-Control
time perspective: Prospective
measure: Depressive symptoms remission or response rates, under usual SSRI treatment.
time frame: 10 weeks of follow up
arm group label: Depressed Patients
description: Patients: Group of patients that are diagnosed for having depression, and are suitable for SSRI treatment.
arm group label: Non-Depressed Controls
description: Controls: Volunteers that had clinical screening with no depression diagnosis.
arm group label: Patients Relatives
description: Patient Relatives (Optional group for later stage): First degree relatives with no depression diagnosis.
Subjects and patients will be asked to give blood samples at 4 points of time for the lab
      processing: micro-RNA and proteome profiling/
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Amichai Hareven
investigator title: Dr Amichai Hareven
mesh term: Depression