- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04052568
Effects of Psilocybin in Anorexia Nervosa
May 4, 2023 updated by: Johns Hopkins University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental psilocybin
Participants will have up to four doses of 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week post final psilocybin session
|
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.
|
2 months post final psilocybin session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month post final psilocybin session
|
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.
|
1 month post final psilocybin session
|
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).
|
3 months post final psilocybin session
|
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.
|
1 month post final psilocybin session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2019
Primary Completion (Actual)
January 5, 2022
Study Completion (Actual)
April 20, 2023
Study Registration Dates
First Submitted
August 8, 2019
First Submitted That Met QC Criteria
August 8, 2019
First Posted (Actual)
August 12, 2019
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00182516
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia Nervosa
-
Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
-
Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Atypical Anorexia NervosaUnited States
Clinical Trials on Psilocybin
-
Yale UniversityHeffter Research Institute; Ceruvia Lifesciences; CH TAC LLCCompleted
-
University of Wisconsin, MadisonTRYP TherapeuticsWithdrawn
-
Yale UniversityCeruvia LifesciencesCompleted
-
King's College LondonUniversity of CambridgeRecruitingAutism Spectrum DisorderUnited Kingdom
-
Section for Affective Disorders; Northern Stockholm...Karolinska Institutet; Vastra Gotaland Region; Region Örebro County; Uppsala University...Not yet recruiting
-
Yale UniversityHeffter Research InstituteActive, not recruitingMajor Depressive DisorderUnited States
-
University Health Network, TorontoCentre for Addiction and Mental HealthRecruitingDepression | Mood Disorders | Major Depressive Disorder | Treatment-Resistant DepressionCanada
-
Yale UniversityTerminated
-
University of Colorado, DenverNot yet recruitingAnhedonia | Major Depressive Disorder | Treatment Resistant DepressionUnited States
-
Multidisciplinary Association for Psychedelic StudiesWithdrawnAnxiety | Stage IV MelanomaUnited States