CompletedPhase 1ketamine

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

NCT ID

NCT04714541

Target Enrollment

5 participants

Start Date

2021-04-12

Est. Completion

2022-07-26

About This Study

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 Studied

Anorexia Nervosa

Interventions

•Ketamine Hcl 50Mg/Ml Inj

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full 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

Study Locations (1)

Lori Calabrese MD Innovative Psychiatry