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/NCT06009003</url>
    </required_header>
    <id_info>
      <org_study_id>REL-1017-EAP</org_study_id>
      <nct_id>NCT06009003</nct_id>
    </id_info>
    <brief_title>REL-1017 Expanded Access Treatment</brief_title>
    <official_title>REL-1017 Expanded Access Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Relmada Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Relmada Therapeutics, Inc.</source>
    <brief_summary>
      <textblock>
        To provide expanded access of REL-1017 to patients with MDD who do not have access to other&#xD;
        effective therapy and are not eligible for other clinical trials with REL-1017&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Available</overall_status>
    <study_type>Expanded Access</study_type>
    <has_expanded_access>No</has_expanded_access>
    <expanded_access_info>
      <expanded_access_type_individual>Yes</expanded_access_type_individual>
      <expanded_access_type_intermediate>Yes</expanded_access_type_intermediate>
    </expanded_access_info>
    <condition>Major Depressive Disorder</condition>
    <condition>Depression</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>REL-1017</intervention_name>
      <description>REL-1017 tablet</description>
      <other_name>esmethadone</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with Major Depressive Disorder who may potentially benefit from treatment&#xD;
               with REL-1017 as determined by the treating physician.&#xD;
  &#xD;
            -  Have undergone appropriate standard treatments without success and in the opinion of&#xD;
               the treating physician no comparable or satisfactory alternative treatment is&#xD;
               available to treat the disease or condition.&#xD;
  &#xD;
            -  Are ineligible or unable to participate in any ongoing clinical study of the&#xD;
               investigational product.&#xD;
  &#xD;
            -  Condition for which, in the opinion of the treating physician, there is sufficient&#xD;
               evidence of a potential benefit from the use of the investigational product, and that&#xD;
               potential benefit outweighs the known or anticipated risks.&#xD;
  &#xD;
            -  There is adequate information to support appropriate dosing for special population&#xD;
               patients such as pediatric, elderly, renal or hepatic disease, etc.&#xD;
  &#xD;
          Exclusion Criteria:&#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;
            -  History of allergy or hypersensitivity to methadone or related drugs.&#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>N/A</maximum_age>
    </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>expandedaccess@relmada.com</email>
    </overall_contact>
    <link>
      <url>https://www.relmada.com/our-portfolio/eap</url>
      <description>Expanded Access Policy</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 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>NMDA receptor antagonist</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/NCT06009003
  org study id: REL-1017-EAP
  nct id: NCT06009003
  lead sponsor: 
  To provide expanded access of REL-1017 to patients with MDD who do not have access to other
        effective therapy and are not eligible for other clinical trials with REL-1017
  expanded access type individual: Yes
  expanded access type intermediate: Yes
  intervention type: Drug
  intervention name: REL-1017
  description: REL-1017 tablet
  other name: esmethadone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Cedric O'Gorman, MD
  role: Study Director
  affiliation: Relmada Therapeutics
  last name: Medical Director
  phone: 786-638-7384
  email: expandedaccess@relmada.com
  url: https://www.relmada.com/our-portfolio/eap
  description: Expanded Access Policy
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major