ClinicalTrials.gg
Enrolling by invitationNCT06736769KETTLEUpdated Oct 13, 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 2026-10-13.

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

In context

Anorexia Nervosa

469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.

This study's planned enrollment of 20 is below the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

This is the only study on the registry with Amanda Downey, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 16-26 years old
  2. Meets diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (atypical AN) per 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

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

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

06

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2024
First posted
Dec 17, 2024
StartActual
Jun 5, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06736769
Lead sponsor
Amanda Downey, MD
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
Oct 13, 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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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drug tested here: Ketamine

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