Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
- Registration Number
- NCT04714541
- Lead Sponsor
- Homeostasis Therapeutics, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ketogenic Diet Adoption Followed by Ketamine Infusion Ketamine Hcl 50Mg/Ml Inj 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
- Primary Outcome Measures
Name Time Method 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
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 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
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Lori Calabrese MD Innovative Psychiatry
🇺🇸South Windsor, Connecticut, United States
Lori Calabrese MD Innovative Psychiatry🇺🇸South Windsor, Connecticut, United States