Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ketogenic Diet Adoption Followed by Ketamine Infusion 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
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
|
Outcome Measures
Primary Outcome Measures
- Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score [Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months]
A 28-item Self Report Scale that Assesses the Range and Severity of ED symptoms
- Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score [Change from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months, 9 Months, 12 Months]
Self Report Scale that Assesses The Indicators of Recovery
- Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale [Change from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months]
A 16-Item Self Administered Rating Scale Which Measures PsychoSocial Impairment
- Change in Behavior and Mood and Thinking as Measured by Interview [Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months]
Qualitative Analysis of Research- Associate Administered Questionnaire
Secondary Outcome Measures
- 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]
Weight to Be Measured By Local Clinician or Support Person to Ensure Safety
Other Outcome Measures
- Breath Acetone Measure [Change from Baseline Daily Week 1,2,3, and 4 ,8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months]
Acetone Measured by Participant with Portable Breath Acetone Meter
- Brief 24- Hour Food Recall [Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months]
Obtained by Research Associate
- 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]
Self Administered Questionnaire
- Change in Depressive Symptoms as Assessed by Patient Health Questionnaire [Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos]
A 9 Item Self Administered Questionnaire
Eligibility Criteria
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
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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
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Willingness to Participant in a 2-Day Program in Central Connecticut
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Identified Support Partner Who Will Attend Program
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Willingness to Have Weight Recorded and Reported by PCP or Support Partner
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Willingness to Attend 4-6 Clinic Visits For Ketamine Infusion
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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
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Bulimia Nervosa as The Primary Diagnosis
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Weight Change of Greater Than 5 Pounds in Last 3 Months
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Pregnancy
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Sexually Active Females Not Using Birth Control
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Interstitial Cystitis
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Unmanaged/Unstable Hypertenison (Greater than 140 Systolic; 90 Diastolic
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Cardiac Arrythmia
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Uncontrolled Seizure Disorder or Seizure Withen 30 Days Prior to Screening
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QTc Interval of 470 ms or Greater
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Current or Past History of Psychotic Disorder
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Active Suicidal Ideation
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lori Calabrese MD Innovative Psychiatry | South Windsor | Connecticut | United States | 06074 |
Sponsors and Collaborators
- Homeostasis Therapeutics, LLC
Investigators
- Principal Investigator: Lori Calabrese, MD, Innovative Psychiatry So Windsor
- Principal Investigator: Lori Calabrese, MD, Innovative Psychiatry, So Windsor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01-2020 ANKK