Status:
COMPLETED
Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
Lead Sponsor:
Homeostasis Therapeutics, LLC
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 Impr...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04714541
Start Date
April 12 2021
End Date
July 26 2022
Last Update
November 4 2022
Active Locations (1)
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1
Lori Calabrese MD Innovative Psychiatry
South Windsor, Connecticut, United States, 06074