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CompletedPhase 1

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

NCT04714541 · Homeostasis Therapeutics, LLC

Closed to entry
Status
Not accepting participants
Phase 1
Phase
5
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score

    Measured over 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

    Measured over 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

    Measured over 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

    Measured over Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
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

Where

1 study site

FacilityCityRegionCountry
Lori Calabrese MD Innovative PsychiatrySouth WindsorConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04714541 on ClinicalTrials.gov →

Last updated in the registry 2022-11-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in