Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04714541
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Homeostasis Therapeutics, LLC

Tracking Information
First Submitted Date  ICMJE January 12, 2021
First Posted Date  ICMJE January 19, 2021
Last Update Posted Date February 12, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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  ICMJE Anorexia Nervosa
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2021)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lori Calabrese, MD 860 648 9755 loricalabresemd@gmail.com
Contact: Barbara Scolnick, MD 6178036353 scolnick@bu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04714541
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Homeostasis Therapeutics, LLC
Study Sponsor  ICMJE Homeostasis Therapeutics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP