Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

Study Overview
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Brief Summary
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This Open-Label Pilot Study Aims to Determine Whether a Two-Part Sequenced Out Patient Procedure Utilizing a Modified Ketogenic Diet Followed by a Series of Titrated Ketamine Infusions Results in Improvement or Remission of Chronic Anorexia Nervosa in Adults with Symptoms of Anorexia for at Least 3 Years Despite Treatment Involving at Least 2 Different Modalities. The Hypothesis is That the Diet Addresses Core Metabolic Deficits in the Anorexic Brain and Primes the Response to Ketamine.

Detailed Description
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Participants Who Are Deemed Eligible Will Participate in an Open-Label Clinical Trial Using a Sequenced Treatment Previously Reported in One Case Study to Result in Complete and Sustained Remission of Anorexia Nervosa for Over One Year (and Continuing). Part 1 Involves a Group 2-Day Immersive In-Person Educational Program to Begin a Modified Ketogenic Diet, Under the Supervision of a Nutritionist Who Has Decades of Experience in Designing Ketogenic Diets for Seizure Patients. This Group Experience is Followed by a 4 Week Period of At-Home Adoption of the Diet, With Close Phone and E-Mail Follow-up. Part 2 Involves Administration of a Series of Titrated Intravenous Ketamine Infusions Scheduled Over 2 Weeks. During Part 1, and Part 2, There Will Be a Range of Objective and Psychological Measures To Assess Safety and Response. The Participants Will be Followed For 12 Months.

Official Title
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Case Series: A Sequenced Treatment Using a Modified Ketogenic Diet and Ketamine for Severe and Enduring Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Drug: Ketamine Hcl 50Mg/Ml Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Between 18 and 65 Anorexia Nervosa Diagnosis For at Least 3 Years Treatment Resistance, as Evidenced by Having Failed at Least 2 Treatments Body Mass Index (BMI) Greater than or Equal to 18.5 Stable Weight for the Last 3 Months (No Consistent Change Greater than 5 Pounds) Abstinence From Substance Abuse for At Least 3 Months No Cannabis Use for At Least 3 Months Currently Under the Care of a Primary Care Provider (PCP) Participant Must Agree to have PCP Contacted by Study Staff Willingness to Participant in a 2-Day Program in Central Connecticut Identified Support Partner Who Will Attend Program Willingness to Have Weight Recorded and Reported by PCP or Support Partner Willingness to Attend 4-6 Clinic Visits For Ketamine Infusion Willingness to Be Contacted for Follow Up for 12 Months Willingness to Abide By All COVID Safety Measures Exclusion Criteria Concomitant Disease (Gastroentestinal, Renal, Respiratory, Cardiac, Etc) or Any Clinically Significant Finding at Screening that Would Pose a Risk to the Participant Primary Carnitine Deficiency, Beta Oxidation Defects, Pyruvate Carboxylase Deficiency, Porphyria, or Treatment with Carbonic Anhydrase Inhibitors Bulimia Nervosa as The Primary Diagnosis Weight Change of Greater Than 5 Pounds in Last 3 Months Pregnancy Sexually Active Females Not Using Birth Control Interstitial Cystitis Unmanaged/Unstable Hypertenison (Greater than 140 Systolic; 90 Diastolic Cardiac Arrythmia Uncontrolled Seizure Disorder or Seizure Withen 30 Days Prior to Screening QTc Interval of 470 ms or Greater Current or Past History of Psychotic Disorder Active Suicidal Ideation Enrolled in any Clinical Trial or Used Any Investigational Agent, Device, and/or Investigational Procedure Within 30 Days Before Screening, or Does so Concurrently With this Study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The 5 Participants Undergo A Sequenced Treatment of Adopting A Ketogenic Diet For at Least 4 Weeks, Followed by A Series of Intravenous Ketamine Infusions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic Diet Adoption Followed by Ketamine Infusion<br>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 | Drug: Ketamine Hcl 50Mg/Ml Inj<br>* Racemic Ketamine Will Be Infused At A Starting Dose of 0.75 mg/kg Over A Period of 45 Minutes. The Dose Will be Titrated, Based on Clinical Signs With Changes of 0.3mg/kg Up to Maximum of 0.95 mg/kg, and Lowest Dose of 0.3 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score | A 28-item Self Report Scale that Assesses the Range and Severity of ED symptoms | Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months | 
| Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score | Self Report Scale that Assesses The Indicators of Recovery | Change from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months, 9 Months, 12 Months | 
| Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale | A 16-Item Self Administered Rating Scale Which Measures PsychoSocial Impairment | Change from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months | 
| Change in Behavior and Mood and Thinking as Measured by Interview | Qualitative Analysis of Research- Associate Administered Questionnaire | Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight/Body Mass Index | Weight to Be Measured By Local Clinician or Support Person to Ensure Safety | 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 |