Ketamine Effects on Learning in Eating Disorders... — Clinical Trial Details

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.

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

Company

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Ketamine Effects on Learning in Eating Disorders (KETTLE)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Ketamine infusion

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details