<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/NCT03775200</url>
  </required_header>
  <id_info>
    <org_study_id>COMP001</org_study_id>
    <nct_id>NCT03775200</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression</brief_title>
  <acronym>P-TRD</acronym>
  <official_title>The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>COMPASS Pathways</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>COMPASS Pathways</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>
      The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a&#xD;
      dose-ranging study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">September 27, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</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>Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3</measure>
    <time_frame>Change from Baseline to Week 3</time_frame>
    <description>MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response &gt;= 50% decrease and remission &lt;= 10 total score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MADRS Change From Baseline to Week 3, Sensitivity Analysis</measure>
    <time_frame>Change from Baseline to Week 3</time_frame>
    <description>MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response &gt;= 50% decrease and remission &lt;= 10 total score.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">233</enrollment>
  <condition>Treatment Resistant Depression</condition>
  <arm_group>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose Psilocybin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium dose Psilocybin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose Psilocybin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psilocybin</intervention_name>
    <description>Dose-finding</description>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_label>Medium dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of TRD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other comorbidities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kadima Neuropsychiatry Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altman Clinical and Translational Research Institute, University of California</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Department of Psychiatry</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mood and Anxiety Disorders Program Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ray Worthy Psychiatry LLC</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70123</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>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Center of Excellence on Mood Disorders, University of Texas Health Science Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canadian Rapid Treatment Centre of Excellence</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Mental Health Czech Republic</name>
      <address>
        <city>Klecany</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallaght University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groningen University Medical Centre</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Centre</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utrecht University Medical Centre</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade de Neuropsiquiatria, Centro Clinico Champalimaud</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Dia Numancia</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Hospital del Mar of Medical Research (IMIM)</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research and Imaging Centre</name>
      <address>
        <city>Bristol</city>
        <state>Avon</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolfson Research Centre, Campus for Ageing and Vitality</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>Tyne And Wear</state>
        <zip>NE4 5PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Pancras Clinical Research</name>
      <address>
        <city>London</city>
        <zip>EC2Y 8EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College London, Institute of Psychiatry, Psychology and Neurology</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Manchester Mental Health Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <results_first_submitted>February 7, 2023</results_first_submitted>
  <results_first_submitted_qc>April 21, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 24, 2023</results_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</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>
    <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03775200/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03775200/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First patient first visit: 1 March 2019 Last patients last visit: 27 September 2021</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>25 mg COMP360 Psilocybin</title>
          <description>25 mg COMP360 Psilocybin</description>
        </group>
        <group group_id="P2">
          <title>10 mg COMP360 Psilocybin</title>
          <description>10 mg COMP360 Psilocybin</description>
        </group>
        <group group_id="P3">
          <title>1 mg COMP360 Psilocybin</title>
          <description>1 mg COMP360 Psilocybin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="75"/>
                <participants group_id="P3" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included all randomised participants who received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>25 mg COMP360 Psilocybin</title>
          <description>25 mg COMP360 Psilocybin</description>
        </group>
        <group group_id="B2">
          <title>10 mg COMP360 Psilocybin</title>
          <description>10 mg COMP360 Psilocybin</description>
        </group>
        <group group_id="B3">
          <title>1 mg COMP360 Psilocybin</title>
          <description>1 mg COMP360 Psilocybin</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="79"/>
            <count group_id="B2" value="75"/>
            <count group_id="B3" value="79"/>
            <count group_id="B4" value="233"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="77"/>
                    <measurement group_id="B4" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>Age at Screening</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.2" spread="12.19"/>
                    <measurement group_id="B2" value="40.6" spread="12.76"/>
                    <measurement group_id="B3" value="38.7" spread="11.71"/>
                    <measurement group_id="B4" value="39.8" spread="12.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ireland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3</title>
        <description>MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response &gt;= 50% decrease and remission &lt;= 10 total score.</description>
        <time_frame>Change from Baseline to Week 3</time_frame>
        <population>The full analysis set includes all participants randomised who receive study drug and have at least 1 post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>25 mg COMP360 Psilocybin</title>
            <description>25 mg COMP360 Psilocybin</description>
          </group>
          <group group_id="O2">
            <title>10 mg COMP360 Psilocybin</title>
            <description>10 mg COMP360 Psilocybin</description>
          </group>
          <group group_id="O3">
            <title>1 mg COMP360 Psilocybin</title>
            <description>1 mg COMP360 Psilocybin</description>
          </group>
        </group_list>
        <measure>
          <title>Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3</title>
          <description>MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response &gt;= 50% decrease and remission &lt;= 10 total score.</description>
          <population>The full analysis set includes all participants randomised who receive study drug and have at least 1 post-dose efficacy assessment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12" spread="12.98"/>
                    <measurement group_id="O2" value="-8.9" spread="10.94"/>
                    <measurement group_id="O3" value="-6.8" spread="11.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Hypothetical strategy estimand - missing not at random (MNAR) and missing at random (MAR) imputation for missing data.</method_desc>
            <param_type>Least Mean Square Difference</param_type>
            <param_value>-6.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.86</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.2</ci_lower_limit>
            <ci_upper_limit>-2.9</ci_upper_limit>
            <estimate_desc>LSM difference of COMP360 25 mg compared to COMP360 1 mg.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MADRS Change From Baseline to Week 3, Sensitivity Analysis</title>
        <description>MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response &gt;= 50% decrease and remission &lt;= 10 total score.</description>
        <time_frame>Change from Baseline to Week 3</time_frame>
        <population>The per-protocol analysis set includes all participants in the Full Analysis Set who do not have a protocol deviation that is thought to significantly affect the integrity of the participant's efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>25 mg COMP360 Psilocybin</title>
            <description>25 mg COMP360 Psilocybin</description>
          </group>
          <group group_id="O2">
            <title>10 mg COMP360 Psilocybin</title>
            <description>10 mg COMP360 Psilocybin</description>
          </group>
          <group group_id="O3">
            <title>1 mg COMP360 Psilocybin</title>
            <description>1 mg COMP360 Psilocybin</description>
          </group>
        </group_list>
        <measure>
          <title>MADRS Change From Baseline to Week 3, Sensitivity Analysis</title>
          <description>MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response &gt;= 50% decrease and remission &lt;= 10 total score.</description>
          <population>The per-protocol analysis set includes all participants in the Full Analysis Set who do not have a protocol deviation that is thought to significantly affect the integrity of the participant's efficacy data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12" spread="12.98"/>
                    <measurement group_id="O2" value="-8.9" spread="11.11"/>
                    <measurement group_id="O3" value="-6.7" spread="11.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Sensitivity analysis of the primary endpoint using the per-protocol analysis set.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Hypothetical strategy estimand - MNAR and MAR imputation for missing data.</method_desc>
            <param_type>Least Mean Square Difference</param_type>
            <param_value>-5.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.93</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.4</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 12 Weeks</time_frame>
      <desc>The Safety Analysis Set included all randomised participants who received study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>25 mg COMP360 Psilocybin</title>
          <description>25 mg COMP360 Psilocybin</description>
        </group>
        <group group_id="E2">
          <title>10 mg COMP360 Psilocybin</title>
          <description>10 mg COMP360 Psilocybin</description>
        </group>
        <group group_id="E3">
          <title>1 mg COMP360 Psilocybin</title>
          <description>1 mg COMP360 Psilocybin</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="75"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal behaviour</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Adjustment disorder with anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Adjustment disorder with mixed anxiety and depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalisation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="75"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="79"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="75"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="34" subjects_affected="27" subjects_at_risk="79"/>
                <counts group_id="E2" events="22" subjects_affected="16" subjects_at_risk="75"/>
                <counts group_id="E3" events="30" subjects_affected="20" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="79"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="75"/>
                <counts group_id="E3" events="16" subjects_affected="14" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="75"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="75"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Panic reaction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Thinking abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="75"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Compass Pathways</organization>
      <phone>07443136539</phone>
      <email>info@compasspathways.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03775200
org study id: COMP001
nct id: NCT03775200
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a
      dose-ranging study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
time frame: Change from Baseline to Week 3
description: MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score.
measure: MADRS Change From Baseline to Week 3, Sensitivity Analysis
time frame: Change from Baseline to Week 3
description: MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score.
arm group label: Low dose
arm group type: Experimental
description: Low dose Psilocybin
arm group label: Medium dose
arm group type: Experimental
description: Medium dose Psilocybin
arm group label: High dose
arm group type: Experimental
description: High dose Psilocybin
intervention type: Drug
intervention name: Psilocybin
description: Dose-finding
arm group label: High dose
arm group label: Low dose
arm group label: Medium dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Canada
country: Czechia
country: Denmark
country: Germany
country: Ireland
country: Netherlands
country: Portugal
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant
mesh term: Psilocybin
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 