Clinical trial NCT04714541: Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
Official title: Case Series: A Sequenced Treatment Using a Modified Ketogenic Diet and Ketamine for Severe and Enduring Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anorexia Nervosa
Lead sponsor: Homeostasis Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score
timeFrame: Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months
measure: Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score
timeFrame: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months, 9 Months, 12 Months
measure: Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale
timeFrame: Change from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months
measure: Change in Behavior and Mood and Thinking as Measured by Interview
timeFrame: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months
Secondary outcomes:
measure: Change in Body Weight/Body Mass Index
timeFrame: 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:
measure: Breath Acetone Measure
timeFrame: Change from Baseline Daily Week 1,2,3, and 4 ,8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months
measure: Brief 24- Hour Food Recall
timeFrame: Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months
measure: Change in Food Preference as Assessed by The Geiselman Food Preference Questionnaire
timeFrame: Change from Baseline at 4 Weeks, 8 Weeks, then 3 Months, 6 Months, 9 Months 12 Months
measure: Change in Depressive Symptoms as Assessed by Patient Health Questionnaire
timeFrame: Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos
Locations:
city: South Windsor
country: United States
facility: Lori Calabrese MD Innovative Psychiatry
state: Connecticut
Study officials:
affiliation: Innovative Psychiatry So Windsor
name: Lori Calabrese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovative Psychiatry, So Windsor
name: Lori Calabrese, MD
role: PRINCIPAL_INVESTIGATOR
References: