Anorexia NervosaPhase 2NCT04661514
Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
A Phase 2 study testing Psilocybin in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 10 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 40 years of age at Screening
- Current diagnosis of Anorexia Nervosa (informed by DSM 5) based on medical records, clinical assessment, weight, and documented completion of the version 7.0.2 Mini International Neuropsychiatric Interview (MINI)
- Agree for the study team to maintain contact with their primary care team for the duration of the study.
- Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Who cannot join
- Medical exclusion criteria will be determined during the Screening Period and Baseline. Exclusion assessments that will be rechecked on the day of dosing are marked with an Asterix.
- BMI < 16 kg/m2 *
- Medical instability as indicated by significant (>3kg) weight loss during the screening period, orthostatic heart rate and blood pressure *
- Women who are pregnant, nursing, or planning a pregnancy in the near future. Male and female participants who are sexually active must agree to use a highly effective contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening visits and Baseline, and psilocybin dosing session days *
- Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent myocardial infarction (<1 year from signing of ICF), uncontrolled hypertension (blood pressure >140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
- Uncontrolled or insulin-dependent diabetes.
Show all 19Show fewer
- Seizure disorder.
- Use of psychedelics, including psilocybin, within one year prior to Screening assessment
- Positive urine drug screen for illicit drugs or drugs of abuse in the Screening Period and Baseline and psilocybin dosing days. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion *
- Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening
- Abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at Screening, such as liver function tests (LFTs) three times greater than the upper limit of normal, reduced glomerular filtration rate (GFR) and elevated creatinin two times of upper limit of normal
- Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study
- Non-English speakers
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, significant history of mania, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder as assessed by medical history and a structured clinical interview
- McLean Screening Instrument for Borderline Personality Disorder >7 at Screening
- Currently taking a serotonergic medication. All serotonergic medication must be discontinued at least two weeks prior to Baseline.
- Current (within the last year) alcohol or substance use disorder as informed by DSM-5 at Screening
- Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the Colombia-Suicide Severity Rating Scale (C-SSRS) within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during subject interview (pre-treatment Baseline sessions).
- Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin, including exposure to psilocybin within the past year and use of psychedelics, such as ayahuasca, during the current episode.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
About this study
The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.
Read the detailed description
Because there are no proven treatments that normalize core symptoms in adult anorexia nervosa, a disorder with high chronicity, many individuals seek out alternative approaches to care. Recent evidence has suggested that anxiety, obsessive compulsive disorder, and diminished reward or motivation play key roles in the development and maintenance of dysfunctional eating, and poor outcome. In recent years, a growing number of studies have demonstrated the safety and preliminary efficacy of psilocybin in clinical trials for a range of psychiatric illnesses including treatment resistant depression, obsessive compulsive disorder, addiction, and anxiety. Psilocybin may represent a promising new treatment for anorexia nervosa. However, no studies have tested psilocybin in this eating disorder population. Accordingly, this study aims to establish the safety, tolerability and dosing of psilocybin in adult patients with anorexia nervosa, as well as gather pilot data on possible efficacy.
For this study, the investigators will recruit adults who currently have a DSM-V diagnosis of anorexia nervosa. Participants will undergo medical and psychological screening and those who are deemed eligible will partake in a maximum of 7 study visits, lasting from 4-8 weeks. On dosing day, participants will receive a single 25 mg dose of psilocybin along with psychotherapeutic support, which includes preparation and integration sessions surrounding the experience. There will be a follow-up period of one month following the psilocybin session during which a range of psychological measures (questionnaires and interviews) will be collected.
- Conditions
- Anorexia Nervosa
- Being tested
- Psilocybin
- Keywords
- Anorexia, Anorexia Nervosa Signs and Symptoms, Eating Disorders, Mental Disorders, Psilocybin, Hallucinogens, Physiological Effects of Drugs, Psychotropic Drugs, Psychedelic Drugs
- Medical subject headings
- Anorexia Nervosa, Anorexia, Feeding and Eating Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin-assisted psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Safety, Tolerability, and Treatment | Experimental | On dosing day, each participant will receive 1 x 25 mg treatment bottle containing 5 x 5 mg oral capsules of psilocybin. The administration session will last approximately 4-6 hours and will be supported by a lead therapist and an assisting therapist. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and occurrence of changes in AEs
Measured: Baseline to Day 28
Incidence and occurrence of changes in AEs
Measured: Day 1 to Day 28
Incidence of clinically important changes in ECG parameters
Measured: Baseline to Day 1
Incidence of clinically important changes in ECG parameters
Measured: Baseline to Day 7
Incidence of clinically important changes in ECG parameters
Measured: Baseline to Day 28
Incidence of clinically important changes in laboratory tests
Measured: Baseline to Day 1
Incidence of clinically important changes in laboratory tests
Measured: Baseline to Day 7
Incidence of clinically important changes in laboratory tests
Measured: Baseline to Day 28
Incidence of clinically significant changes in vital signs
Measured: Baseline to Day 1
Incidence of clinically significant changes in vital signs
Measured: Baseline to Day 7
Incidence of clinically significant changes in vital signs
Measured: Baseline to Day 28
Incidence of changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) at each post-Baseline visit
The C-SSRS will be used to assess suicide potential or tendency as a study entry criteria and monitored throughout the study.
Measured: Baseline to Day 28
Secondary outcomes (8)
Change in Eating Disorder Examination (EDE) scores for Dietary Restraint, Eating Concern, and Shape Concern
The EDE is a structured clinical interview (investigator rated) and is used to measure the severity of the characteristic psychopathology of eating disorders. The four EDE subscales (Dietary Restraint, Eating Concern, Weight Concern, and Shape Concern) are rated on a 7-point forced-choice format (0-6), with higher scores reflecting greater severity or frequency.
Measured: Baseline to Day 28
Change in weight (kg)
Measured: Baseline to Day 7 and Day 28
Change in trait anxiety and state anxiety total scores on the Spielberger State-Trait Anxiety Inventory (STAI)
The STAI consists of self-report scales for measuring "state" and "trait" anxiety. It consists of 40 items scored by a 4 point Likert scale. 20 questions refer to state anxiety, and 20 to trait anxiety thus each section is scored between 20 and 80. Higher scores indicate greater anxiety.
Measured: Baseline to Day 1, Day 7, and Day 28
Change in Physical Appearance State and Trait Anxiety Scale (PASTAS) trait total score and state score
The PASTAS is a self-reported 16-item measure that assesses anxiety about physical appearance. Each question is rated on a Likert scale from 0 to 4, indicating that the individual feels anxious, tense or nervous about a specific body part or general overweightness. There is a minimum score on each scale 0 and a maximum score of 64, where higher scores indicated greater severity in anxiety.
Measured: Baseline to Day 1, Day 7, and Day 28
Change in Body Image State Scale (BISS) total score
The BISS is a self-report questionnaire that has six items used to assess an individual's evaluative and affecting body image state at a given moment in time. The six items are: 1) dissatisfaction with physical appearance, 2) dissatisfaction with body size and shape, 3) dissatisfaction with weight, 4) feelings of physical unattractiveness, 5) current feeling about one's look relative to how one usually feels, and 6) evaluation of one's appearance relative to how the average person looks. Each item is evaluated on a 9-point bipolar Likert like scale and higher scores indicate more positive body image.
Measured: Baseline to Day 28
Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS-SRQ)
This self-report scale consists of 65 items and 19 question items related to eating disorder preoccupations and rituals. There is an emphasis on comparison between current state (last two weeks) and worst state, the one month where the participant believed their eating disorder to be the most severe. The scoring includes a preoccupations subtotal, rituals subtotal and total score.
Measured: Baseline to Day 1, Day 7, and Day 28
Change in Eating Disorder Inventory (EDI) total score
The EDI is a self-report questionnaire. It consists of 91 items organized into 12 primary scales rated on a 0-4 point scoring system, consisting of 3 eating disorder specific scales and 9 general psychological scales that are highly relevant to, but not specific to, eating disorders. It yields six composite scores: one that is eating disorder specific (i.e., Eating Disorder Risk) and five that are general integrative psychological constructs (i.e., Ineffectiveness, Interpersonal Problems, Affective Problems, Overcontrol, General Psychological Maladjustment). A computer-based scoring program generates a detailed clinical profile and scoring report for each participant.
Measured: Baseline to Day 1, Day 7, and Day 28
Change in Eating Disorder Examination Questionnaire Short Form (EDE-QS) total scores
The EDE-QS is a self-report questionnaire. It consists of 32 items that assess the core symptoms of eating disorders and range of eating-related psychopathology. The EDE-QS is based closely on the EDE interview. Scores range from 0 to 36 and higher scores indicate greater eating disorder symptoms.
Measured: Baseline to Day 1, Day 7, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 May 2021
- Primary completion10 Mar 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- COMPASS Pathways
- Responsible party
- Principal investigator, Walter Kaye, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661514
- Sponsor's protocol ID
- 049345
- Status last verified
- Jul 2022
- First submitted
- 19 Nov 2020
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Peck SK, Shao S, Gruen T, Yang K, Babakanian A, Trim J, Finn DM, Kaye WH. Psilocybin Therapy for Females With Anorexia Nervosa: A Phase 1, Open-Label Feasibility Study. Focus (Am Psychiatr Publ). 2024 Jul;22(3):381-387. doi: 10.1176/appi.focus.24022013. Epub 2024 Jun 28.
PubMed 38988455Peck SK, Shao S, Gruen T, Yang K, Babakanian A, Trim J, Finn DM, Kaye WH. Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. Nat Med. 2023 Aug;29(8):1947-1953. doi: 10.1038/s41591-023-02455-9. Epub 2023 Jul 24.
PubMed 37488291
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT04661514
- Acronym / sponsor ID
- 049345
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia, Anorexia Nervosa Signs and Symptoms, Eating Disorders, Mental Disorders, Psilocybin, Hallucinogens, Physiological Effects of Drugs, Psychotropic Drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- COMPASS Pathways
- Study start
- 1 May 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.
Detailed description
Because there are no proven treatments that normalize core symptoms in adult anorexia nervosa, a disorder with high chronicity, many individuals seek out alternative approaches to care. Recent evidence has suggested that anxiety, obsessive compulsive disorder, and diminished reward or motivation play key roles in the development and maintenance of dysfunctional eating, and poor outcome. In recent years, a growing number of studies have demonstrated the safety and preliminary efficacy of psilocybin in clinical trials for a range of psychiatric illnesses including treatment resistant depression, obsessive compulsive disorder, addiction, and anxiety. Psilocybin may represent a promising new treatment for anorexia nervosa. However, no studies have tested psilocybin in this eating disorder population. Accordingly, this study aims to establish the safety, tolerability and dosing of psilocybin in adult patients with anorexia nervosa, as well as gather pilot data on possible efficacy.
For this study, the investigators will recruit adults who currently have a DSM-V diagnosis of anorexia nervosa. Participants will undergo medical and psychological screening and those who are deemed eligible will partake in a maximum of 7 study visits, lasting from 4-8 weeks. On dosing day, participants will receive a single 25 mg dose of psilocybin along with psychotherapeutic support, which includes preparation and integration sessions surrounding the experience. There will be a follow-up period of one month following the psilocybin session during which a range of psychological measures (questionnaires and interviews) will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety, Tolerability, and Treatment | Experimental | Drug: PsilocybinOn dosing day, each participant will receive 1 x 25 mg treatment bottle containing 5 x 5 mg oral capsules of psilocybin. The administration session will last approximately 4-6 hours and will be supported by a lead therapist and an assisting therapist. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 40 years of age at Screening
- Current diagnosis of Anorexia Nervosa (informed by DSM 5) based on medical records, clinical assessment, weight, and documented completion of the version 7.0.2 Mini International Neuropsychiatric Interview (MINI)
- Agree for the study team to maintain contact with their primary care team for the duration of the study.
- Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Key exclusion criteria (19 listed)
- Medical exclusion criteria will be determined during the Screening Period and Baseline. Exclusion assessments that will be rechecked on the day of dosing are marked with an Asterix.
- BMI < 16 kg/m2 *
- Medical instability as indicated by significant (>3kg) weight loss during the screening period, orthostatic heart rate and blood pressure *
- Women who are pregnant, nursing, or planning a pregnancy in the near future. Male and female participants who are sexually active must agree to use a highly effective contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening visits and Baseline, and psilocybin dosing session days *
- Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent myocardial infarction (<1 year from signing of ICF), uncontrolled hypertension (blood pressure >140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinPsilocybin-assisted psychotherapy | Drug | Safety, Tolerability, and Treatment |
Primary outcome
Incidence and occurrence of changes in AEs
Time frame: Baseline to Day 28
Incidence and occurrence of changes in AEs
Time frame: Day 1 to Day 28
Incidence of clinically important changes in ECG parameters
Time frame: Baseline to Day 1
Incidence of clinically important changes in ECG parameters
Time frame: Baseline to Day 7
Incidence of clinically important changes in ECG parameters
Time frame: Baseline to Day 28
Incidence of clinically important changes in laboratory tests
Time frame: Baseline to Day 1
Incidence of clinically important changes in laboratory tests
Time frame: Baseline to Day 7
Incidence of clinically important changes in laboratory tests
Time frame: Baseline to Day 28
Incidence of clinically significant changes in vital signs
Time frame: Baseline to Day 1
Incidence of clinically significant changes in vital signs
Time frame: Baseline to Day 7
Incidence of clinically significant changes in vital signs
Time frame: Baseline to Day 28
Incidence of changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) at each post-Baseline visit
Time frame: Baseline to Day 28
The C-SSRS will be used to assess suicide potential or tendency as a study entry criteria and monitored throughout the study.
8 secondary outcomes
Change in Eating Disorder Examination (EDE) scores for Dietary Restraint, Eating Concern, and Shape Concern
Time frame: Baseline to Day 28
Change in weight (kg)
Time frame: Baseline to Day 7 and Day 28
Change in trait anxiety and state anxiety total scores on the Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Baseline to Day 1, Day 7, and Day 28
Change in Physical Appearance State and Trait Anxiety Scale (PASTAS) trait total score and state score
Time frame: Baseline to Day 1, Day 7, and Day 28
Change in Body Image State Scale (BISS) total score
Time frame: Baseline to Day 28
Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS-SRQ)
Time frame: Baseline to Day 1, Day 7, and Day 28
Change in Eating Disorder Inventory (EDI) total score
Time frame: Baseline to Day 1, Day 7, and Day 28
Change in Eating Disorder Examination Questionnaire Short Form (EDE-QS) total scores
Time frame: Baseline to Day 1, Day 7, and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 38988455Peck SK, Shao S, Gruen T, Yang K, Babakanian A, Trim J, Finn DM, Kaye WH. Psilocybin Therapy for Females With Anorexia Nervosa: A Phase 1, Open-Label Feasibility Study. Focus (Am Psychiatr Publ). 2024 Jul;22(3):381-387. doi: 10.1176/appi.focus.24022013. Epub 2024 Jun 28.
- Derived from this study: PubMed 37488291Peck SK, Shao S, Gruen T, Yang K, Babakanian A, Trim J, Finn DM, Kaye WH. Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. Nat Med. 2023 Aug;29(8):1947-1953. doi: 10.1038/s41591-023-02455-9. Epub 2023 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and occurrence of changes in AEs (time frame: Baseline to Day 28). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.