Ketamine Effects on Learning In Eating Disorders

NCT06736769 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 3 other identifiers: KL2TR001870P054101424--42123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Atypical Anorexia Nervosa

Keywords

Anxiety; Depression; Anorexia; Psychotropic Drugs; Feeding and Eating Disorders; Physiological Effects of Drugs; Cognitive Flexibility

Outcome Measures

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.

  Day 2, Day 4

Study Arms (1)

Ketamine Infusion

EXPERIMENTAL

Drug: Ketamine infusion

Interventions

Ketamine infusion DRUG

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

Ketamine Infusion

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amanda Downey, MD: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Anxiety Disorders; Depression; Anorexia; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda E. Downey, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: June 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)