<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/NCT04433858</url>
  </required_header>
  <id_info>
    <org_study_id>14947563</org_study_id>
    <nct_id>NCT04433858</nct_id>
  </id_info>
  <brief_title>An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)</brief_title>
  <official_title>An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheppard Pratt Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>COMPASS Pathways</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheppard Pratt Health System</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg)&#xD;
      administered under supportive conditions to adult participants with severe TRD, in improving&#xD;
      depressive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Anticipated">October 24, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 24, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery Asberg Depression Rating Scale (MADRS)</measure>
    <time_frame>From Baseline (Day -1) to three weeks post-dose.</time_frame>
    <description>MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = &gt;50% decrease and Remission =&lt; 10 actual score.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Treatment Resistant Depression</condition>
  <arm_group>
    <arm_group_label>Psilocybin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25mg of Psilocybin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psilocybin</intervention_name>
    <description>open-label</description>
    <arm_group_label>Psilocybin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of at least moderate Major Depressive Disorder (MDD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbidities&#xD;
&#xD;
        Note for CA sites: Only Veterans are Eligible&#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>Scott Aaronson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheppard Pratt Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Exploratory Therapeutics Laboatory</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Palo Alto Healthcare System/Stanford Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheppard Pratt Health System</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheppard Pratt Health System</investigator_affiliation>
    <investigator_full_name>Scott T. Aaronson, M.D</investigator_full_name>
    <investigator_title>Director, Clinical Research Programs</investigator_title>
  </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>
    <mesh_term>Depressive Disorder, Treatment-Resistant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psilocybin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04433858
org study id: 14947563
nct id: NCT04433858
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg)
      administered under supportive conditions to adult participants with severe TRD, in improving
      depressive symptoms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Montgomery Asberg Depression Rating Scale (MADRS)
time frame: From Baseline (Day -1) to three weeks post-dose.
description: MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score.
arm group label: Psilocybin
arm group type: Experimental
description: 25mg of Psilocybin
intervention type: Drug
intervention name: Psilocybin
description: open-label
arm group label: Psilocybin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Scott Aaronson, MD
role: Principal Investigator
affiliation: Sheppard Pratt Health System
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sheppard Pratt Health System
investigator full name: Scott T. Aaronson, M.D
investigator title: Director, Clinical Research Programs
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant
mesh term: Psilocybin
sharing ipd: No