Ketamine Effects on Learning In Eating Disorders (KETTLE)

June 10, 2026 updated by: Amanda Downey, MD

"KETTLE" Trial: Ketamine Effects on Learning In Eating Disorders

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine Infusion
Drug: Ketamine infusion
Ketamine will be delivered intravenously at 0.5 mg/kg over 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Reversal Learning
Time Frame: Day 2, Day 4
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.
Day 2, Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amanda Downey, MD

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Amanda E. Downey, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KL2TR001870 (U.S. NIH Grant/Contract)
  • P0541014 (Other Identifier: UCSF Clinical and Translational Science Institute (CTSI) Proposal Number)
  • 24--42123 (Other Identifier: UCSF Institutional Review Board Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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