Ketamine Effects on Learning In Eating Disorders

NCT ID: NCT06736769

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine Infusion

Group Type: EXPERIMENTAL

Ketamine infusion

Intervention Type: DRUG

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

Interventions

Ketamine infusion

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Amanda Downey, MD

OTHER

Sponsor Role: lead

Responsible Party

Amanda Downey, MD

Assistant Professor of Pediatrics and Psychiatry and Behavioral Sciences

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amanda E. Downey, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

KL2TR001870

Identifier Type: NIH

Identifier Source: secondary_id

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P0541014

Identifier Type: OTHER

Identifier Source: secondary_id

24--42123

Identifier Type: OTHER

Identifier Source: secondary_id

KL2TR001870

Identifier Type: NIH

Identifier Source: org_study_id

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