CClinicalTrials.gg
Enrolling by invitationNCT06736769KETTLEUpdated Jun 12, 2026

Ketamine Effects on Learning In Eating Disorders

A Phase 2 interventional study of Ketamine infusion in Anorexia Nervosa and Atypical Anorexia Nervosa, sponsored by Amanda Downey, MD. Enrolling by invitation at 1 site in United States. Open to participants aged 16 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Amanda Downey, MD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
16 Years to 26 Years
Sex
All
01

Study summary

This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.

02

Conditions studied

  • Anorexia Nervosa
  • Atypical Anorexia Nervosa

Keywords

  • Anxiety
  • Depression
  • Anorexia
  • Psychotropic Drugs
  • Feeding and Eating Disorders
  • Physiological Effects of Drugs
  • Cognitive Flexibility
03

Who can participate

Ages eligible
16 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 16-26 years old
  2. Meets diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (atypical AN) per DSM-5 criteria on admission
  3. Admitted to the medical hospital for malnutrition
  4. No changes to psychiatric medications for month prior to trial enrollment
  5. Agree to use a highly effective form of contraception for at least two weeks following ketamine administration
  6. Have an outpatient primary care provider, medical provider, or behavioral health provider or psychiatrist who is actively managing or coordinating care

Exclusion criteria

Exclusion Criteria:

  1. Lifetime history of any psychotic disorder
  2. Moderate or severe substance use disorder
  3. Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial
  4. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment
  5. Intellectual or developmental disability
  6. High risk for self-harm/suicide
  7. Active laxative misuse or abuse
  8. Biochemical refeeding syndrome or electrolyte abnormality
  9. Cardiac abnormalities identified on admission
  10. Taking medications that would be unsafe to administer with ketamine
  11. Other medical condition or diagnosis, physical exam finding, laboratory abnormality, or health risk that would increase the risk of adverse events, at the discretion of the investigators
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Ketamine Infusion

    Drug: Ketamine infusion

Interventions

  • DrugKetamine infusion

    Ketamine will be delivered intravenously at 0.5 mg/kg over 40 minutes.

05

What researchers measure

Primary outcomes

  1. Mean Change From Baseline in Reversal Learning

    Mean change in reversal learning as measured by the probabilistic reversal learning task.In the task, participants are presented with two stimuli, told to choose one of the two stimuli on each trial, and receive feedback regarding whether the stimulus is "Correct" or "Incorrect." Participants must modify their choice based on c hanging stimulus-outcome contingencies over time, engaging flexible learning.

    Time frame: Day 2, Day 4

06

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94158, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06736769
Lead sponsor
Amanda Downey, MD
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Responsible party
Amanda Downey, MD (Assistant Professor of Pediatrics and Psychiatry and Behavioral Sciences, University of California, San Francisco) — Sponsor-investigator
First posted
Dec 17, 2024
Start date
Jun 5, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jun 12, 2026

Study contacts

Amanda E. Downey, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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