<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/NCT02981225</url>
  </required_header>
  <id_info>
    <org_study_id>PiL-Obs-RSDep-015</org_study_id>
    <nct_id>NCT02981225</nct_id>
  </id_info>
  <brief_title>Management Strategy for Mild to Moderate Major Depression: Combination of Rhodiola and Saffron Extracts.</brief_title>
  <official_title>Descriptive Study of a Phytotherapy Management Strategy for Mild to Moderate Major Depression With Phytostandard® Rhodiola-Saffron : a Combination of Rhodiola and Saffron Extracts.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PiLeJe</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PiLeJe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms&#xD;
      in patients with mild to moderate major depression in a strategy with Phytostandard®&#xD;
      Rhodiola-Saffron supplementation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, 52 patients are going to be included. They will have a supplementation of&#xD;
      Phytostandard® rhodiola/saffron, from 2 tablets per day during 42 days.&#xD;
&#xD;
      on the one hand, during the two visits (inclusion and follow-up), the investigator completes&#xD;
      the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression (CGI). During the&#xD;
      inclusion visit, he completes with his patient CIM-10 for depression diagnostic.&#xD;
&#xD;
      on the other hand, patients complete HAD 4 times : just after the inclusion visit, at day 14,&#xD;
      at day 28 and just before the follow-up visit. He completes the Patient Global Impression too&#xD;
      at each time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</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>Evolution of HAM-D scale</measure>
    <time_frame>between day 0 and day 42</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of HAD patient scale</measure>
    <time_frame>between day 0 and day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of CGI</measure>
    <time_frame>between day 0 and day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of PGI</measure>
    <time_frame>between day 0 and day 42</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">59</enrollment>
  <condition>Mild to Moderate Depression</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Phytostandard® Rhodiola-Saffron</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from mild to moderate depression&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suffering from mild to moderate depression as defined in CIM-10&#xD;
&#xD;
          -  Having a score on the HAM-D questionnaire between 8 and 18&#xD;
&#xD;
          -  Having agreed to participate at the study after being informed by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Depressive patients already under medication or discontinuation of medication less&#xD;
             than a month ago&#xD;
&#xD;
          -  Patients with severe depression as defined in CIM-10 or HAM-D&gt; 18&#xD;
&#xD;
          -  Patients considered at risk: attempted suicide or suicidal (observed by the&#xD;
             investigator or Hamilton item 3 score&gt; 2)&#xD;
&#xD;
          -  Patients with psychiatric disorders: schizophrenia, bipolarity, addiction (drugs,&#xD;
             alcohol ...), etc.&#xD;
&#xD;
          -  Patient with severe disease (cancer, kidney or heart disease) or patient with a&#xD;
             contra-indication for taking the product (patient under anti-hypertensive ...)&#xD;
&#xD;
          -  Patients using agents containing piperine or St. John's wort (interactions)&#xD;
&#xD;
          -  Pregnant or breastfeeding patients&#xD;
&#xD;
          -  Patients who do not wish to complement Phytostandard® Rhodiola - Saffron.&#xD;
&#xD;
          -  Patients who do not wish to participate in the study.&#xD;
&#xD;
          -  Patients unable to understand the ins and outs of the study (mental incapacity,&#xD;
             language barrier).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pileje</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</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>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT02981225
org study id: PiL-Obs-RSDep-015
nct id: NCT02981225
lead sponsor: 
has dmc: No
The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms
      in patients with mild to moderate major depression in a strategy with Phytostandard®
      Rhodiola-Saffron supplementation
For this study, 52 patients are going to be included. They will have a supplementation of
      Phytostandard® rhodiola/saffron, from 2 tablets per day during 42 days.

      on the one hand, during the two visits (inclusion and follow-up), the investigator completes
      the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression (CGI). During the
      inclusion visit, he completes with his patient CIM-10 for depression diagnostic.

      on the other hand, patients complete HAD 4 times : just after the inclusion visit, at day 14,
      at day 28 and just before the follow-up visit. He completes the Patient Global Impression too
      at each time.
observational model: Cohort
time perspective: Prospective
measure: Evolution of HAM-D scale
time frame: between day 0 and day 42
measure: Evolution of HAD patient scale
time frame: between day 0 and day 42
measure: Evolution of CGI
time frame: between day 0 and day 42
measure: Evolution of PGI
time frame: between day 0 and day 42
intervention type: Dietary Supplement
intervention name: Phytostandard® Rhodiola-Saffron
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder