Ketamine Effects on Learning In Eating Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine infusion.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa, Atypical Anorexia Nervosa. Basic parameters: 16 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
"KETTLE" Trial: Ketamine Effects on Learning In Eating Disorders
Overview
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.
Interventions
- Drug Ketamine infusion
Ketamine will be delivered intravenously at 0.5 mg/kg over 40 minutes.
Primary outcome measures
- Mean Change From Baseline in Reversal Learning [Time frame: Day 2, Day 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06736769 · KL2TR001870 · KL2TR001870 · P0541014 · 24--42123