xml: <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/NCT06011577</url>
    </required_header>
    <id_info>
      <org_study_id>REL-1017-304</org_study_id>
      <nct_id>NCT06011577</nct_id>
    </id_info>
    <brief_title>Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD</brief_title>
    <acronym>RELIGHT</acronym>
    <official_title>A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Relmada Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Relmada Therapeutics, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in&#xD;
        patients with major depressive disorder (MDD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind,&#xD;
        placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an&#xD;
        adjunctive treatment of Major Depressive Disorder in patients with inadequate response to&#xD;
        ongoing background antidepressant treatment. Eligible patients will continue to take their&#xD;
        background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017&#xD;
        or placebo for a 4 week treatment period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>Yes</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in MADRS Total Score From Baseline to Day 28</measure>
      <time_frame>Day 28</time_frame>
      <description>The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Major Depressive Disorder</condition>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>REL-1017 25 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>REL-1017</intervention_name>
      <description>REL-1017 tablet</description>
      <arm_group_label>REL-1017 25 mg</arm_group_label>
      <other_name>esmethadone</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo tablet</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female outpatients, 18-65 years of age, inclusive.&#xD;
  &#xD;
            -  Currently meets DSM-5 criteria for MDD without psychotic features, based on the&#xD;
               SCID-5-CT, with a current major depressive episode (MDE).&#xD;
  &#xD;
            -  Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Psychiatric hospitalization during the current major depressive episode.&#xD;
  &#xD;
            -  History or presence of clinically significant health conditions which in the opinion&#xD;
               of the Investigator would negatively impact the safety of the participant.&#xD;
  &#xD;
            -  Participants who, in the Investigator's judgment, are at significant risk for suicide.&#xD;
  &#xD;
            -  Pregnant or planning to become pregnant.&#xD;
  &#xD;
            -  Breast-feeding or planning to breast-feed.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cedric O'Gorman, MD</last_name>
      <role>Study Director</role>
      <affiliation>Relmada Therapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Medical Director</last_name>
      <phone>786-638-7384</phone>
      <email>clinicaltrials@relmada.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Culver City</city>
          <state>California</state>
          <zip>90230</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Newport Beach</city>
          <state>California</state>
          <zip>92660</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Sherman Oaks</city>
          <state>California</state>
          <zip>91403</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Brandon</city>
          <state>Florida</state>
          <zip>33511</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32256</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33174</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21208</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Springfield</city>
          <state>Massachusetts</state>
          <zip>33024</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Toms River</city>
          <state>New Jersey</state>
          <zip>08755</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Cedarhurst</city>
          <state>New York</state>
          <zip>11516</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Franklin</city>
          <state>Tennessee</state>
          <zip>37067</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Bellaire</city>
          <state>Texas</state>
          <zip>77401</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Wichita Falls</city>
          <state>Texas</state>
          <zip>76309</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Relmada Site</name>
        <address>
          <city>Draper</city>
          <state>Utah</state>
          <zip>84020</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.relightstudies.com</url>
      <description>Study Homepage</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</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 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>REL-1017</keyword>
    <keyword>esmethadone</keyword>
    <keyword>Relmada</keyword>
    <keyword>antidepressant</keyword>
    <keyword>adjunctive</keyword>
    <keyword>NMDA receptor antagonist</keyword>
    <keyword>Relight</keyword>
    <keyword>Depression</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>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011577
  org study id: REL-1017-304
  nct id: NCT06011577
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in
        patients with major depressive disorder (MDD).
  This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind,
        placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an
        adjunctive treatment of Major Depressive Disorder in patients with inadequate response to
        ongoing background antidepressant treatment. Eligible patients will continue to take their
        background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017
        or placebo for a 4 week treatment period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in MADRS Total Score From Baseline to Day 28
  time frame: Day 28
  description: The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
  arm group label: REL-1017 25 mg
  arm group type: Experimental
  description: During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)
  intervention type: Drug
  intervention name: REL-1017
  description: REL-1017 tablet
  arm group label: REL-1017 25 mg
  other name: esmethadone
  intervention type: Drug
  intervention name: Placebo
  description: Placebo tablet
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Cedric O'Gorman, MD
  role: Study Director
  affiliation: Relmada Therapeutics
  last name: Medical Director
  phone: 786-638-7384
  email: clinicaltrials@relmada.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  url: http://www.relightstudies.com
  description: Study Homepage
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major