Clinical TrialEating DisordersKetamineCompleted

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

This open-label pilot study (n=5) aims to investigate whether a two-part outpatient procedure, utilising a modified ketogenic diet followed by a series of titrated ketamine infusions, can lead to improvements or remission of chronic anorexia nervosa in adults who have experienced symptoms for at least three years despite undergoing treatment involving at least two different modalities.

Target Enrollment
5 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label, single-group pilot (n=5): participants complete a 2‑day immersive ketogenic diet education then 4 weeks of home diet adoption before receiving a series of titrated IV ketamine infusions over 2 weeks (starting 0.75 mg/kg, titrated up to 0.95 mg/kg; infusions ~45 minutes).

Safety and clinical response are assessed with objective and psychological measures during both parts and participants are followed for 12 months.

Study Protocol

Preparation

2 sessions

Dosing

6 sessions
45 min each

Integration

sessions

Study Arms & Interventions

Ketogenic diet + ketamine

experimental

All participants adopt a modified ketogenic diet for ≥4 weeks followed by a series of titrated intravenous ketamine infusions over 2 weeks.

Interventions

  • Ketamine0.75 - 0.95 mg/kg
    via IV• series over 2 weeks• 6 doses total

    Infused over 45 minutes; dose titrated by ~0.3 mg/kg based on clinical signs; lowest 0.3 mg/kg.

  • Compound
    via Other• single period

    Modified ketogenic diet: 2-day in-person education then 4 weeks home adoption with dietitian support and remote follow-up.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment5 participants
  • Timeline
    Start: 2021-04-12
    End: 2022-07-26
  • Compound
    Ketamine
  • Topic
    Eating Disorders

Locations

Lori Calabrese MD Innovative Psychiatry — South Windsor, Connecticut, United States

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