Anorexia Nervosa
Conditions
Brief summary
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
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.
Interventions
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
Sponsors
Homeostasis Therapeutics, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score | Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months | A 28-item Self Report Scale that Assesses the Range and Severity of ED symptoms |
| Change in Behavior and Mood and Thinking as Measured by Interview | Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months | Qualitative Analysis of Research- Associate Administered Questionnaire |
| Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale | Change from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months | A 16-Item Self Administered Rating Scale Which Measures PsychoSocial Impairment |
| Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score | Change from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months, 9 Months, 12 Months | Self Report Scale that Assesses The Indicators of Recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight/Body Mass Index | 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 | Weight to Be Measured By Local Clinician or Support Person to Ensure Safety |
Other
| Measure | Time frame | Description |
|---|---|---|
| Breath Acetone Measure | Change from Baseline Daily Week 1,2,3, and 4 ,8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months | Acetone Measured by Participant with Portable Breath Acetone Meter |
| Change in Depressive Symptoms as Assessed by Patient Health Questionnaire | Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos | A 9 Item Self Administered Questionnaire |
| Change in Food Preference as Assessed by The Geiselman Food Preference Questionnaire | Change from Baseline at 4 Weeks, 8 Weeks, then 3 Months, 6 Months, 9 Months 12 Months | Self Administered Questionnaire |
| Brief 24- Hour Food Recall | Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months | Obtained by Research Associate |
Countries
United States
Outcome results
None listed