Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Homeostasis Therapeutics, LLC
• Treatments: Ketamine

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