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NMDA Receptor Antagonist
Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
Phase 1
Waitlist Available
Led By Lori Calabrese, MD
Research Sponsored by Homeostasis Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline biweekly for weeks 1,2,3, and 4, weekly for weeks 5,6,7,8.then 3 months, 6 months, 9 months, 12 months s and prior to every ketamine infusion 8 weeks; 3 months; 6 months; 9 months;12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial tests a two-step treatment for adults with long-term anorexia who haven't improved with other treatments. First, patients follow a special high-fat, low-carb diet to prepare their brains. Then, they receive specific amounts of ketamine through a drip. The goal is to see if this combination can improve or cure their anorexia.
Eligible Conditions
- Eating Disorders
- Anorexia Nervosa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline biweekly for weeks 1,2,3, and 4, weekly for weeks 5,6,7,8.then 3 months, 6 months, 9 months, 12 months s and prior to every ketamine infusion 8 weeks; 3 months; 6 months; 9 months;12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline biweekly for weeks 1,2,3, and 4, weekly for weeks 5,6,7,8.then 3 months, 6 months, 9 months, 12 months s and prior to every ketamine infusion 8 weeks; 3 months; 6 months; 9 months;12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Behavior and Mood and Thinking as Measured by Interview
Eating Disorders
Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score
+1 moreSecondary study objectives
Change in Body Weight/Body Mass Index
Other study objectives
Breath Acetone Measure
Brief 24- Hour Food Recall
Change in Depressive Symptoms as Assessed by Patient Health Questionnaire
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: Ketogenic Diet Adoption Followed by Ketamine InfusionExperimental Treatment1 Intervention
All 5 Participants Will Be Educated to Adopt a Ketogenic Diet, As Outpatient. After at Least 4 Weeks on the Diet, They Will Have A Series of Titrated Intravenous Ketamine Infusions Over A 2 Week Period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Homeostasis Therapeutics, LLCLead Sponsor
Lori Calabrese, MDPrincipal InvestigatorInnovative Psychiatry, So Windsor