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NCT06736769 | NOT YET RECRUITING | Anorexia Nervosa

Ketamine Effects on Learning In Eating Disorders
Sponsor:

Amanda Downey, MD

Information provided by (Responsible Party):

Amanda Downey, MD

Brief 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.

Condition or disease

Anorexia Nervosa

Atypical Anorexia Nervosa

Intervention/treatment

Ketamine infusion

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : "KETTLE" Trial: Ketamine Effects on Learning In Eating Disorders
Actual Study Start Date : 2025-05-15
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years to 26 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Ketamine Effects on Learning In Eating Disorders

Location Details

NCT06736769

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

University of California, San Francisco

San Francisco, California, United States, 94158