Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

November 1, 2022 updated by: Homeostasis Therapeutics, LLC

Case Series: A Sequenced Treatment Using a Modified Ketogenic Diet and Ketamine for Severe and Enduring Anorexia Nervosa

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • South Windsor, Connecticut, United States, 06074
        • Lori Calabrese MD Innovative Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months
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 from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months, 9 Months, 12 Months
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 from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months
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
Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline Daily Week 1,2,3, and 4 ,8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months
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 from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months
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 from Baseline at 4 Weeks, 8 Weeks, then 3 Months, 6 Months, 9 Months 12 Months
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
Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Homeostasis Therapeutics, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lori Calabrese, MD, Innovative Psychiatry So Windsor
  • Principal Investigator: Lori Calabrese, MD, Innovative Psychiatry, So Windsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-2020 ANKK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anorexia Nervosa

Clinical Trials on Ketamine Hcl 50Mg/Ml Inj

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings