Clinical trial NCT04661514: Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
Official title: Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Keywords: Anorexia
Anorexia Nervosa Signs and Symptoms
Eating Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Psychedelic Drugs
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: COMPASS Pathways
First posted: 2020-12-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 18 to 40 years of age at Screening
2. 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)
3. Agree for the study team to maintain contact with their primary care team for the duration of the study.
4. Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

Exclusion Criteria:

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.

1. BMI \< 16 kg/m2 \*
2. Medical instability as indicated by significant (\>3kg) weight loss during the screening period, orthostatic heart rate and blood pressure \*
3. 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 \*
4. 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.
5. Uncontrolled or insulin-dependent diabetes.
6. Seizure disorder.
7. Use of psychedelics, including psilocybin, within one year prior to Screening assessment
8. 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 \*
9. Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening
10. 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
11. 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
12. Non-English speakers
13. 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
14. McLean Screening Instrument for Borderline Personality Disorder \>7 at Screening
15. Currently taking a serotonergic medication. All serotonergic medication must be discontinued at least two weeks prior to Baseline.
16. Current (within the last year) alcohol or substance use disorder as informed by DSM-5 at Screening
17. 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).
18. 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.

Primary outcomes:
measure: Incidence and occurrence of changes in AEs
timeFrame: Baseline to Day 28
measure: Incidence and occurrence of changes in AEs
timeFrame: Day 1 to Day 28
measure: Incidence of clinically important changes in ECG parameters
timeFrame: Baseline to Day 1
measure: Incidence of clinically important changes in ECG parameters
timeFrame: Baseline to Day 7
measure: Incidence of clinically important changes in ECG parameters
timeFrame: Baseline to Day 28
measure: Incidence of clinically important changes in laboratory tests
timeFrame: Baseline to Day 1
measure: Incidence of clinically important changes in laboratory tests
timeFrame: Baseline to Day 7
measure: Incidence of clinically important changes in laboratory tests
timeFrame: Baseline to Day 28
measure: Incidence of clinically significant changes in vital signs
timeFrame: Baseline to Day 1
measure: Incidence of clinically significant changes in vital signs
timeFrame: Baseline to Day 7
measure: Incidence of clinically significant changes in vital signs
timeFrame: Baseline to Day 28
measure: Incidence of changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) at each post-Baseline visit
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Change in Eating Disorder Examination (EDE) scores for Dietary Restraint, Eating Concern, and Shape Concern
timeFrame: Baseline to Day 28
measure: Change in weight (kg)
timeFrame: Baseline to Day 7 and Day 28
measure: Change in trait anxiety and state anxiety total scores on the Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Change in Physical Appearance State and Trait Anxiety Scale (PASTAS) trait total score and state score
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Change in Body Image State Scale (BISS) total score
timeFrame: Baseline to Day 28
measure: Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS-SRQ)
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Change in Eating Disorder Inventory (EDI) total score
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Change in Eating Disorder Examination Questionnaire Short Form (EDE-QS) total scores
timeFrame: Baseline to Day 1, Day 7, and Day 28
Other outcomes:
measure: Change in Quick Inventory of Depressive Symptomatology (QIDS) total score
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Change in Clinical Impairment Assessment (CIA) total scores
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Change in Visual Analogue Scales (VAS) measures
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Change in Eating Disorder readiness to change and motivation for change (ED-RR)
timeFrame: Baseline to Day 1, Day 7, and Day 28
measure: Summary of the 5D-Altered states of consciousness questionnaire (5D-ASC) on the day of psilocybin dosing
timeFrame: Dosing Day
measure: Correlation between psychedelic intensity and experience and eating disorder psychopathology
timeFrame: Dosing Day, Day 1, Day 28
measure: Patient experience and acceptability of the treatment summarized
timeFrame: Dosing Day, Day 1, Day 28
Locations:
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
Study officials:
References: