Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

NCT04714541 | Completed Phase 1 FDA Drug

• 1 other identifier: 01-2020 ANKK
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (4)

• 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 from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months

• Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score

  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

  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

  Qualitative Analysis of Research- Associate Administered Questionnaire

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

Secondary Outcomes (1)

• Change in Body Weight/Body Mass Index

  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 Outcomes (4)

• Breath Acetone Measure

  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

  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

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

Study Arms (1)

Ketogenic Diet Adoption Followed by Ketamine Infusion

EXPERIMENTAL

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

Interventions

Ketamine Hcl 50Mg/Ml Inj DRUG

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

Ketogenic Diet Adoption Followed by Ketamine Infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Homeostasis Therapeutics, LLC: lead

Study Sites (1)

Lori Calabrese MD Innovative Psychiatry

South Windsor, Connecticut, 06074, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Lori Calabrese, MD

  Innovative Psychiatry So Windsor

  PRINCIPAL INVESTIGATOR

• Lori Calabrese, MD

  Innovative Psychiatry, So Windsor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: April 12, 2021
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)