Anorexia NervosaPhase 1NCT04714541
Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
A Phase 1 study testing Ketamine Hcl 50Mg/Ml Inj in people with Anorexia Nervosa, run by Homeostasis Therapeutics, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Ketamine Hcl 50Mg/Ml Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 26 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lori Calabrese MD Innovative Psychiatry
South Windsor, Connecticut, 06074
About this study
Official title: Case Series: A Sequenced Treatment Using a Modified Ketogenic Diet and Ketamine for Severe and Enduring Anorexia Nervosa
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Ketamine Hcl 50Mg/Ml Inj
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Hcl 50Mg/Ml InjDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ketamine Hcl 50Mg/Ml Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score
A 28-item Self Report Scale that Assesses the Range and Severity of ED symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months
Secondary outcomes (1)
Change in Body Weight/Body Mass Index
Weight to Be Measured By Local Clinician or Support Person to Ensure Safety
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start12 Apr 2021
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Homeostasis Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori Calabrese, MD, Principal investigator, Innovative Psychiatry So WindsorLori Calabrese, MD, Principal investigator, Innovative Psychiatry, So Windsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714541
- Sponsor's protocol ID
- 01-2020 ANKK
- Status last verified
- Nov 2022
- First submitted
- 12 Jan 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series: A Sequenced Treatment Using a Modified Ketogenic Diet and Ketamine for Severe and Enduring Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04714541
- Acronym / sponsor ID
- 01-2020 ANKK
- Conditions
- Anorexia Nervosa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Homeostasis Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet Adoption Followed by Ketamine Infusion | Experimental | Drug: Ketamine Hcl 50Mg/Ml InjAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine Hcl 50Mg/Ml InjRacemic 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 | Drug | Ketogenic Diet Adoption Followed by Ketamine Infusion |
Primary outcome
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
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Calabrese, MD principal investigator
Innovative Psychiatry So Windsor
Lori Calabrese, MD principal investigator
Innovative Psychiatry, So Windsor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine Hcl 50Mg/Ml Inj in people with Anorexia Nervosa, run by Homeostasis Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.