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Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT04714541
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Homeostasis Therapeutics, LLC

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
Anorexia Nervosa Drug: Ketamine Hcl 50Mg/Ml Inj 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Case Series: A Sequenced Treatment Using a Modified Ketogenic Diet and Ketamine for Severe and Enduring Anorexia Nervosa
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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




Primary Outcome Measures :
  1. Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score [ Time Frame: 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

  2. Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score [ Time Frame: 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

  3. Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale [ Time Frame: 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

  4. Change in Behavior and Mood and Thinking as Measured by Interview [ Time Frame: 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 :
  1. Change in Body Weight/Body Mass Index [ Time Frame: 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:
  1. Breath Acetone Measure [ Time Frame: 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

  2. Brief 24- Hour Food Recall [ Time Frame: Change from Baseline Weeks1,2,3,4 then, 8 Weeks, 3 Months, 6 Months, 9 Months 12 Months ]
    Obtained by Research Associate

  3. Change in Food Preference as Assessed by The Geiselman Food Preference Questionnaire [ Time Frame: Change from Baseline at 4 Weeks, 8 Weeks, then 3 Months, 6 Months, 9 Months 12 Months ]
    Self Administered Questionnaire

  4. Change in Depressive Symptoms as Assessed by Patient Health Questionnaire [ Time Frame: Change from Baseline at Week 4, 5, 6, and 3 Months, 6 Months, 9 Months 12 Mos ]
    A 9 Item Self Administered Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714541


Contacts
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Contact: Lori Calabrese, MD 860 648 9755 loricalabresemd@gmail.com
Contact: Barbara Scolnick, MD 6178036353 scolnick@bu.edu

Locations
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United States, Connecticut
Lori Calabrese MD Innovative Psychiatry Recruiting
South Windsor, Connecticut, United States, 06074
Contact: Lori Calabrese, MD    860-648-8481    drc@innovativepsychiatry.com   
Sponsors and Collaborators
Homeostasis Therapeutics, LLC
Investigators
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Principal Investigator: Lori Calabrese, MD Innovative Psychiatry So Windsor
Principal Investigator: Lori Calabrese, MD Innovative Psychiatry, So Windsor
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Responsible Party: Homeostasis Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04714541    
Other Study ID Numbers: 01-2020 ANKK
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Ketamine
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action