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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic Diet Adoption Followed by Ketamine Infusion | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hcl 50Mg/Ml Inj | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Brief 24- Hour Food Recall |
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Lori Calabrese, MD | Innovative Psychiatry So Windsor | Principal Investigator |
| Lori Calabrese, MD | Innovative Psychiatry, So Windsor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lori Calabrese MD Innovative Psychiatry | South Windsor | Connecticut | 06074 | United States |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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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
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Obtained by Research Associate
| Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months |
| 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 |
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |