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Effects of Psilocybin in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT04052568
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE August 12, 2019
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE August 26, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • Change in Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: 1 week post final psilocybin session ]
    The HADS is a 14-item self-report questionnaire that assesses both anxiety (7 questions) and depression (7 questions). Each question is scored on a 4-point Likert scale from 0-3, with higher scores indicating more severe symptoms.
  • Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS) [ Time Frame: 2 months post final psilocybin session ]
    This is a 40-item self-report measure of health related quality of life that is specifically developed for eating disorder populations. Each question is rated on a 5 point scale from 1-5, with higher scores indicating better quality of life.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • Change in the State-Trait Anxiety Inventory (STAI) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    The STAI is a 40-item self-report scale that measures both state and trait anxiety. Scores either component range from 20 to 80 with a higher score indicating higher levels of anxiety.
  • Change in Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    The HADS is a 14-item self-report questionnaire that assesses both anxiety (7 questions) and depression (7 questions). Each question is scored on a 4-point Likert scale from 0-3, with higher scores indicating more severe symptoms.
  • Change in Beck Depression Inventory (BDI) Score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    The BDI is a 21-item self-report scale, rating severity of depressive symptoms on a 4-point Likert scale ranging from 0-3. Total scores range from 0-63 with higher scores indicating higher levels of depressive symptoms.
  • Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS) [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    This is a 40-item self-report measure of health related quality of life that is specifically developed for eating disorder populations. Each question is rated on a 5 point scale from 1-5, with higher scores indicating better quality of life.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • Change in Eating Disorder Examination Questionnaire (EDE-Q) score [ Time Frame: 1 month post final psilocybin session ]
    This is a 28-item self-report score that measures severity of eating disorder symptoms across four domains that each make up a sub-scale: dietary restraint, eating concern, weight concern, and shape concern. A global score is calculated by averaging sub-scale scores. Sub-scale and global scores range from 0-6 with higher scores indicating higher severity.
  • Change in Eating Disorder Examination (EDE) score [ Time Frame: 1 month post final psilocybin session ]
    This is clinician-administered interview that measures severity of eating disorder symptoms across four domains that each make up a sub-scale: dietary restraint, eating concern, weight concern, and shape concern. A global score is calculated by averaging sub-scale scores.
  • Change in Body mass index (BMI) [ Time Frame: 3 months post final psilocybin session ]
    This is a measure of body mass calculated from height and weight (Kg/m^2).
  • Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score [ Time Frame: 1 month post final psilocybin session ]
    The ANSOCQ is a 20-item self-administered questionnaire that places respondents in one of the five stages of change based on Prochaska and DiClemente's model. The maximum raw score is 100, with higher scores indicating higher levels of motivation. An overall classification of the stage of change is obtained by dividing the raw score by 5.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • Change in Eating Disorder Examination Questionnaire (EDE-Q) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months post second psilocybin session ]
    This is a 28-item self-report score that measures severity of eating disorder symptoms across four domains that each make up a sub-scale: dietary restraint, eating concern, weight concern, and shape concern. A global score is calculated by averaging sub-scale scores. Sub-scale and global scores range from 0-6 with higher scores indicating higher severity.
  • Change in Body mass index (BMI) [ Time Frame: 3 months ]
    This is a measure of body mass calculated from height and weight (Kg/m^2).
  • Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months post second psilocybin session ]
    The ANSOCQ is a 20-item self-administered questionnaire that places respondents in one of the five stages of change based on Prochaska and DiClemente's model. The maximum raw score is 100, with higher scores indicating higher levels of motivation. An overall classification of the stage of change is obtained by dividing the raw score by 5.
  • Change in Food preference as assessed by food choice task [ Time Frame: Baseline, 1 and 6 months post second psilocybin session ]
    The investigators will assess food preference using a validated food choice task in which participants are shown images of a variety of food items and are asked to rate the subjective healthiness and tastiness of each item.
  • Change in Food preference as assessed by the Geiselman Food Preference Questionnaire (FPQ) [ Time Frame: Baseline, 1 and 6 months post second psilocybin session ]
    The Geiselman Food Preference Questionnaire is a validated questionnaire that assesses preference for a variety of foods on a 9-point Likert scale with higher scores indicating higher preference. From these responses, a fat preference score is calculated from responses with a score of <100 indicating below average fat preference, and scores >100 indicating above average fat preference.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Psilocybin in Anorexia Nervosa
Official Title  ICMJE Effects of Psilocybin in Anorexia Nervosa
Brief Summary This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely produced in people with AN when psilocybin is administered in a supportive setting with close follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in people with AN, that it will reduce measures of anxiety and depression, and that it will lead to increased quality of life. The investigators will also assess a number of exploratory measures related to eating disorder pathophysiology.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anorexia Nervosa
Intervention  ICMJE Drug: Psilocybin
Participants will undergo up to four moderate to high dose psilocybin sessions. Dosing at the first session will be 20 mg. For subsequent sessions participants will either remain at their previous dose, or increase by increments of 5 mg up to a maximum of 30 mg.
Study Arms  ICMJE Experimental: Experimental psilocybin
Participants will have up to four doses of psilocybin.
Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

General Inclusion Criteria:

  • Currently meet criteria for AN restricting subtype by Diagnostic and Statistical Manual 5th edition (DSM-5) criteria, and have a history of AN for at least 3 years prior to screening
  • Have at least one prior attempt at treatment
  • Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (complete blood count, comprehensive metabolic panel, urine pregnancy test, urine toxicology screen).
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.

General Exclusion Criteria:

  • Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of childbearing potential and sexually active who are not practicing an effective means of birth control.
  • Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, heart valve, or transient ischemic attack in the past year. Resting heart rate may be no less than 50 beats per minute unless cleared by a cardiologist.
  • Epilepsy with history of seizures
  • Type 1 diabetes
  • First degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder
  • Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Natalie Gukasyan, M.D. 410-550-2253 hopkinsanorexiastudy@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04052568
Other Study ID Numbers  ICMJE IRB00182516
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roland Griffiths, Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP