Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

• ClinicalTrials.gov Identifier: NCT04714541
• Recruitment Status: Recruiting
• First Posted: January 19, 2021
• Last Update Posted: February 12, 2021
• Sponsor: Homeostasis Therapeutics, LLC
• Information provided by (Responsible Party): Homeostasis Therapeutics, LLC

Tracking Information

• First Submitted Date: January 12, 2021
• First Posted Date: January 19, 2021
• Last Update Posted Date: February 12, 2021
• Estimated Study Start Date: April 2021
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2021)

• Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Behavior and Mood and Thinking as Measured by Interview [ Time Frame: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months ]
  Qualitative Analysis of Research- Associate Administered Questionnaire

Original Primary Outcome Measures (submitted: January 15, 2021)

Eating Restraint as Measured by Eating Disorder Examination [ Time Frame: Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months ]

A self administered questionnaire measuring eating disorder symptoms

Current Secondary Outcome Measures (submitted: February 9, 2021)

Change in Body Weight/Body Mass Index [ Time Frame: 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

Original Secondary Outcome Measures (submitted: January 15, 2021)

Eating Concerns as Measured by Eating Disorder Examination [ Time Frame: Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months ]

Self Administered Questionniare

Current Other Pre-specified Outcome Measures (submitted: February 9, 2021)

• Breath Acetone Measure [ Time Frame: 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
• Brief 24- Hour Food Recall [ Time Frame: Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months ]
  Obtained by Research Associate
• Change in Food Preference as Assessed by The Geiselman Food Preference Questionnaire [ Time Frame: Change from Baseline at 4 Weeks, 8 Weeks, then 3 Months, 6 Months, 9 Months 12 Months ]
  Self Administered Questionnaire
• Change in Depressive Symptoms as Assessed by Patient Health Questionnaire [ Time Frame: Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos ]
  A 9 Item Self Administered Questionnaire

Original Other Pre-specified Outcome Measures (submitted: January 15, 2021)

• Shape Concerns as Measured by Eating Disorder Examination [ Time Frame: Change from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months ]
  Self Administered Questionnaire
• Weight Concern as Measured by Eating Disorder Examination [ Time Frame: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months ]
  Self Administered Questionnaire
• Body Mass Index [ Time Frame: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months; 9 Months; 12 Months ]
  Measurement of body height and weight

Descriptive Information

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

• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
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

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Anorexia Nervosa

Intervention

Drug: Ketamine Hcl 50Mg/Ml Inj

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

Study Arms

Experimental: Ketogenic Diet Adoption Followed by Ketamine Infusion

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

Intervention: Drug: Ketamine Hcl 50Mg/Ml Inj

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 15, 2021): 5
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lori Calabrese, MD; 860 648 9755; loricalabresemd@gmail.com

Contact: Barbara Scolnick, MD; 6178036353; scolnick@bu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04714541
• Other Study ID Numbers: 01-2020 ANKK
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Homeostasis Therapeutics, LLC
• Study Sponsor: Homeostasis Therapeutics, LLC
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lori Calabrese, MD; Innovative Psychiatry So Windsor
• Principal Investigator: Lori Calabrese, MD; Innovative Psychiatry, So Windsor

• PRS Account: Homeostasis Therapeutics, LLC
• Verification Date: February 2021