Clinical TrialEating DisordersKetamineEnrolling by invitation

Ketamine Effects on Learning in Eating Disorders (KETTLE)

This open-label, Phase II trial (n=20) will study the effects of a single intravenous (IV) dose of ketamine (35mg/70kg; 0.5 mg/kg over 40 minutes) on cognitive flexibility in adolescents and young adults (ages 16–26) medically hospitalised for anorexia nervosa or atypical anorexia nervosa.

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Single-site, single-group study delivering one IV ketamine infusion (0.5 mg/kg over 40 minutes) to medically hospitalised adolescents and young adults with anorexia nervosa or atypical anorexia nervosa to assess effects on learning and cognitive flexibility.

Eating-disorder symptoms and measures of cognitive flexibility will be assessed pre- and post-infusion; investigators hypothesise ketamine will increase cognitive flexibility and improve the ability to form new, positive associations with food.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Ketamine infusion

experimental

Single-group single IV infusion of ketamine for medically hospitalised adolescents and young adults with anorexia nervosa or atypical anorexia nervosa.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    0.5 mg/kg (≈35 mg per 70 kg) IV infusion over 40 minutes

Participants

Ages
16 – 26
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2025-02-07
    End: 2026-06-01
  • Compound
    Ketamine
  • Topic
    Eating Disorders

Locations

University of California, San Francisco — San Francisco, California, United States

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