<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/NCT04505189</url>
  </required_header>
  <id_info>
    <org_study_id>19HH5267</org_study_id>
    <nct_id>NCT04505189</nct_id>
  </id_info>
  <brief_title>Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study</brief_title>
  <official_title>Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to assess the acceptability and efficacy of treating&#xD;
      anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic&#xD;
      Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal&#xD;
      underpinnings of treatment with psilocybin in this patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anorexia nervosa is the most fatal of all psychiatric conditions. With the current paucity of&#xD;
      effective pharmacological and psychological treatments, and fewer than half of those&#xD;
      diagnosed making a full recovery, there is a great need for new treatment avenues to be&#xD;
      explored. For this study, we will recruit patients who have a primary diagnosis of anorexia&#xD;
      nervosa as defined by DSM-V criteria, which has been established by their specialist ED team&#xD;
      to have been present for at least 3 years, and who have found other forms of treatment&#xD;
      ineffective. Over a period of 6 weeks, participants who are deemed eligible at screening will&#xD;
      partake in 8 study visits, including three psilocybin dosing sessions with varying doses. The&#xD;
      maximum dose of psilocybin a participant will receive in a single session is 25 mg. Across&#xD;
      these 8 visits, there will also be 2 MRI scans, up to 5 EEG recordings and a range of&#xD;
      psychological measures (questionnaires and interviews). There will be a follow-up period of&#xD;
      12 months following the final study visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 28, 2021</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 1/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>
    <masking_description>All participants will receive 3 doses of psilocybin. The maximum dose a participant will receive in a single session is 25 mg.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Readiness and Motivation Questionnaire (RMQ)</measure>
    <time_frame>Baseline - Primary endpoint (6 weeks)</time_frame>
    <description>Increase in readiness and motivation to recover from baseline to primary endpoint, which will be related to long-term improvements in psychopathology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eating Disorder Examination (EDE)</measure>
    <time_frame>Baseline - Primary endpoint (6 weeks) - 6 month follow-up.</time_frame>
    <description>Decrease in eating disorder psychopathology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eating Disorder Examination Questionnaire (EDE-Q)</measure>
    <time_frame>Baseline - Primary endpoint (6 weeks) - 6 month follow-up.</time_frame>
    <description>Decrease in eating disorder psychopathology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Magnetic Resonance Imaging (fMRI)</measure>
    <time_frame>Baseline - Primary endpoint (6 weeks)</time_frame>
    <description>Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psilocybin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psilocybin</intervention_name>
    <description>Psilocybin assisted psychotherapy</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary DSM-V diagnosis of Anorexia Nervosa&#xD;
&#xD;
          2. Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care&#xD;
             team to have likely been present for &gt;3 years&#xD;
&#xD;
          3. Current or past treatments have not been successful to maintain remission from&#xD;
             anorexia&#xD;
&#xD;
          4. Be in the care of a GP and specialist eating disorder team in the UK&#xD;
&#xD;
          5. Have a GP and specialist eating disorder team in the UK who can confirm diagnosis&#xD;
&#xD;
          6. Sufficiently competent in English and mental capacity to provide written informed&#xD;
             consent&#xD;
&#xD;
          7. BMI ≥14kg/m2 and medically stable&#xD;
&#xD;
          8. Capacity to consent&#xD;
&#xD;
          9. Agree to have us maintain contact with an identified next-of-kin for the duration of&#xD;
             the study&#xD;
&#xD;
         10. Agree to have us maintain contact with GP and/or specialist eating disorder team as&#xD;
             required, for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or previously diagnosed psychotic disorder&#xD;
&#xD;
          2. Immediate family member with a diagnosed psychotic disorder&#xD;
&#xD;
          3. Unstable physical condition e.g., rapid weight loss &gt; 2kg in the prior month&#xD;
&#xD;
          4. Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction&#xD;
&#xD;
          5. MRI or EEG contraindications&#xD;
&#xD;
          6. A history of laxative abuse in the last 3 months (more than twice a week for 3 months)&#xD;
&#xD;
          7. History of serious suicide attempts or presence of a suicide/ serious self-harm risk&#xD;
             at screening&#xD;
&#xD;
          8. Currently an involuntary patient&#xD;
&#xD;
          9. Emotionally unstable personality, history of mania, or other psychiatric problem that&#xD;
             the screening clinician feels may jeopardise the therapeutic alliance and/or safe&#xD;
             exposure to psilocybin&#xD;
&#xD;
         10. Blood or needle phobia&#xD;
&#xD;
         11. Positive pregnancy test at screening or during the study, or woman who are&#xD;
             breastfeeding&#xD;
&#xD;
         12. If sexually active, participants who lack appropriate contraceptive measures&#xD;
&#xD;
         13. Drug or alcohol dependence within the last 6 months&#xD;
&#xD;
         14. No email access&#xD;
&#xD;
         15. Patients presenting with abnormal QT interval prolongation at screening or with a&#xD;
             history of this (QTc at screening above 470ms)&#xD;
&#xD;
         16. Patients who are currently, or have recently (within 3 months) been enrolled in&#xD;
             another CTIMP.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Imperial College Hammersmith campus</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 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>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</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/NCT04505189
org study id: 19HH5267
nct id: NCT04505189
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to assess the acceptability and efficacy of treating
      anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic
      Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal
      underpinnings of treatment with psilocybin in this patient group.
Anorexia nervosa is the most fatal of all psychiatric conditions. With the current paucity of
      effective pharmacological and psychological treatments, and fewer than half of those
      diagnosed making a full recovery, there is a great need for new treatment avenues to be
      explored. For this study, we will recruit patients who have a primary diagnosis of anorexia
      nervosa as defined by DSM-V criteria, which has been established by their specialist ED team
      to have been present for at least 3 years, and who have found other forms of treatment
      ineffective. Over a period of 6 weeks, participants who are deemed eligible at screening will
      partake in 8 study visits, including three psilocybin dosing sessions with varying doses. The
      maximum dose of psilocybin a participant will receive in a single session is 25 mg. Across
      these 8 visits, there will also be 2 MRI scans, up to 5 EEG recordings and a range of
      psychological measures (questionnaires and interviews). There will be a follow-up period of
      12 months following the final study visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: All participants will receive 3 doses of psilocybin. The maximum dose a participant will receive in a single session is 25 mg.
measure: Readiness and Motivation Questionnaire (RMQ)
time frame: Baseline - Primary endpoint (6 weeks)
description: Increase in readiness and motivation to recover from baseline to primary endpoint, which will be related to long-term improvements in psychopathology.
measure: Eating Disorder Examination (EDE)
time frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
description: Decrease in eating disorder psychopathology.
measure: Eating Disorder Examination Questionnaire (EDE-Q)
time frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up.
description: Decrease in eating disorder psychopathology.
measure: Functional Magnetic Resonance Imaging (fMRI)
time frame: Baseline - Primary endpoint (6 weeks)
description: Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks.
arm group label: Treatment
arm group type: Experimental
description: Psilocybin
intervention type: Drug
intervention name: Psilocybin
description: Psilocybin assisted psychotherapy
arm group label: Treatment
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa
mesh term: Psilocybin
sharing ipd: No