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OpenTrials
Enrolling by Invitation

NCT Number: NCT06736769

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.

Enrolling by Invitation

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Key information

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lifetime history of any psychotic disorder
  • Moderate or severe substance use disorder
  • 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
  • Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment
  • Intellectual or developmental disability
  • High risk for self-harm/suicide
  • Active laxative misuse or abuse
  • Biochemical refeeding syndrome or electrolyte abnormality
  • Cardiac abnormalities identified on admission
  • Taking medications that would be unsafe to administer with ketamine
  • 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

Treatment and study plan

ketamine infusion

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Amanda Downey, MD

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Acronym: KETTLE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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