Anorexia Nervosa, Atypical Anorexia Nervosa
Conditions
Keywords
Anxiety, Depression, Anorexia, Psychotropic Drugs, Feeding and Eating Disorders, Physiological Effects of Drugs, Cognitive Flexibility
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.
Interventions
Ketamine will be delivered intravenously at 0.5 mg/kg over 40 minutes.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Amanda Downey, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 26 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Reversal Learning | Day 2, Day 4 | 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. |
Countries
United States
Outcome results
None listed