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NMDA Receptor Antagonist
Ketamine Effects on Learning in Eating Disorders (KETTLE Trial)
Phase 2
Waitlist Available
Led By Amanda E. Downey, MD
Research Sponsored by Amanda Downey, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2, day 4
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adolescents and young adults hospitalized with anorexia nervosa or atypical anorexia. Participants must be medically stable enough to receive a ketamine infusion. Specific inclusion and exclusion criteria details are not provided.
What is being tested?
The study tests if a single dose of IV ketamine can help patients with anorexia learn new, positive associations with food by increasing cognitive flexibility, potentially making hospital stays less stressful.
What are the potential side effects?
While specific side effects are not listed for this trial, common side effects of ketamine may include confusion, hallucinations, changes in blood pressure, nausea, dizziness, and blurred vision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 2, day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2, day 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change From Baseline in Reversal Learning
Side effects data
From 2015 Phase 2 trial • 15 Patients • NCT0110025520%
Dizziness
13%
Nausea
13%
Headache
7%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine Infusion
Saline Infusion
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketamine InfusionExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine infusion
2011
Completed Phase 4
~170
Find a Location
Who is running the clinical trial?
Amanda Downey, MDLead Sponsor
National Center for Advancing Translational Sciences (NCATS)NIH
376 Previous Clinical Trials
412,819 Total Patients Enrolled
1 Trials studying Eating Disorders
13 Patients Enrolled for Eating Disorders
Amanda E. Downey, MDPrincipal InvestigatorUniversity of California, San Francisco