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Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine Hcl 50Mg/Ml Inj
Sponsored by
Homeostasis Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lori Calabrese MD Innovative Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketogenic Diet Adoption Followed by Ketamine Infusion

Arm Description

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

Outcomes

Primary Outcome Measures

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 in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score
Self Report Scale that Assesses The Indicators of Recovery
Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale
A 16-Item Self Administered Rating Scale Which Measures PsychoSocial Impairment
Change in Behavior and Mood and Thinking as Measured by Interview
Qualitative Analysis of Research- Associate Administered Questionnaire

Secondary Outcome Measures

Change in Body Weight/Body Mass Index
Weight to Be Measured By Local Clinician or Support Person to Ensure Safety

Full Information

First Posted
January 12, 2021
Last Updated
November 1, 2022
Sponsor
Homeostasis Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04714541
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Homeostasis Therapeutics, LLC

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic Diet Adoption Followed by Ketamine Infusion
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine Hcl 50Mg/Ml Inj
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score
Description
A 28-item Self Report Scale that Assesses the Range and Severity of ED symptoms
Time Frame
Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months
Title
Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score
Description
Self Report Scale that Assesses The Indicators of Recovery
Time Frame
Change from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months, 9 Months, 12 Months
Title
Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale
Description
A 16-Item Self Administered Rating Scale Which Measures PsychoSocial Impairment
Time Frame
Change from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months
Title
Change in Behavior and Mood and Thinking as Measured by Interview
Description
Qualitative Analysis of Research- Associate Administered Questionnaire
Time Frame
Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months
Secondary Outcome Measure Information:
Title
Change in Body Weight/Body Mass Index
Description
Weight to Be Measured By Local Clinician or Support Person to Ensure Safety
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
Other Pre-specified Outcome Measures:
Title
Breath Acetone Measure
Description
Acetone Measured by Participant with Portable Breath Acetone Meter
Time Frame
Change from Baseline Daily Week 1,2,3, and 4 ,8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months
Title
Brief 24- Hour Food Recall
Description
Obtained by Research Associate
Time Frame
Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months
Title
Change in Food Preference as Assessed by The Geiselman Food Preference Questionnaire
Description
Self Administered Questionnaire
Time Frame
Change from Baseline at 4 Weeks, 8 Weeks, then 3 Months, 6 Months, 9 Months 12 Months
Title
Change in Depressive Symptoms as Assessed by Patient Health Questionnaire
Description
A 9 Item Self Administered Questionnaire
Time Frame
Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Calabrese, MD
Organizational Affiliation
Innovative Psychiatry So Windsor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lori Calabrese, MD
Organizational Affiliation
Innovative Psychiatry, So Windsor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lori Calabrese MD Innovative Psychiatry
City
South Windsor
State/Province
Connecticut
ZIP/Postal Code
06074
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

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