Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

NCT04661514 | Completed Phase 2 FDA Drug

• 1 other identifier: 049345
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia; Anorexia Nervosa Signs and Symptoms; Eating Disorders; Mental Disorders; Psilocybin; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Psychedelic Drugs

Outcome Measures

Primary Outcomes (12)

• Incidence and occurrence of changes in AEs

  Baseline to Day 28

• Incidence and occurrence of changes in AEs

  Day 1 to Day 28

• Incidence of clinically important changes in ECG parameters

  Baseline to Day 1

• Incidence of clinically important changes in ECG parameters

  Baseline to Day 7

• Incidence of clinically important changes in ECG parameters

  Baseline to Day 28

• Incidence of clinically important changes in laboratory tests

  Baseline to Day 1

• Incidence of clinically important changes in laboratory tests

  Baseline to Day 7

• Incidence of clinically important changes in laboratory tests

  Baseline to Day 28

• Incidence of clinically significant changes in vital signs

  Baseline to Day 1

• Incidence of clinically significant changes in vital signs

  Baseline to Day 7

• Incidence of clinically significant changes in vital signs

  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.

  Baseline to Day 28

Secondary Outcomes (8)

• Change in Eating Disorder Examination (EDE) scores for Dietary Restraint, Eating Concern, and Shape Concern

  Baseline to Day 28

• Change in weight (kg)

  Baseline to Day 7 and Day 28

• Change in trait anxiety and state anxiety total scores on the Spielberger State-Trait Anxiety Inventory (STAI)

  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

  Baseline to Day 1, Day 7, and Day 28

• Change in Body Image State Scale (BISS) total score

  Baseline to Day 28

Other Outcomes (7)

• Change in Quick Inventory of Depressive Symptomatology (QIDS) total score

  Baseline to Day 1, Day 7, and Day 28

• Change in Clinical Impairment Assessment (CIA) total scores

  Baseline to Day 1, Day 7, and Day 28

• Change in Visual Analogue Scales (VAS) measures

  Baseline to Day 1, Day 7, and Day 28

Study Arms (1)

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.

Drug: Psilocybin

Interventions

Psilocybin DRUG

Psilocybin-assisted psychotherapy

Safety, Tolerability, and Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• COMPASS Pathways: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

Related Publications (2)

• 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.

  PMID: 38988455 DERIVED

• 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. Nat Med. 2023 Aug;29(8):1947-1953. doi: 10.1038/s41591-023-02455-9. Epub 2023 Jul 24.

  PMID: 37488291 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Anorexia; Feeding and Eating Disorders; Mental Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 10, 2020
• Study Start: May 1, 2021
• Primary Completion: March 10, 2022
• Study Completion: June 10, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)