Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714541
• Other study ID #: 01-2020 ANKK
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2021
• Est. completion date: July 26, 2022

Study information

• Verified date: November 2022
• Source: Homeostasis Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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

Locations

Country	Name	City	State
United States	Lori Calabrese MD Innovative Psychiatry	South Windsor	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Homeostasis Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breath Acetone Measure	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
Other	Brief 24- Hour Food Recall	Obtained by Research Associate	Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months
Other	Change in Food Preference as Assessed by The Geiselman Food Preference Questionnaire	Self Administered Questionnaire	Change from Baseline at 4 Weeks, 8 Weeks, then 3 Months, 6 Months, 9 Months 12 Months
Other	Change in Depressive Symptoms as Assessed by Patient Health Questionnaire	A 9 Item Self Administered Questionnaire	Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos
Primary	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
Primary	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
Primary	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
Primary	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	Change in Body Weight/Body Mass Index	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