Ketamine for Anorexia

(KETTLE Trial)

Overseen By Amanda E. Downey, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Amanda Downey, MD

Must not be taking: Unsafe with ketamine

Disqualifiers: Psychotic disorder, Substance use, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single dose of ketamine, administered through an IV, can assist adolescents and young adults hospitalized for anorexia nervosa by facilitating the formation of positive thoughts about food. Researchers hope ketamine will enhance cognitive flexibility, allowing individuals to be more open to new ideas and experiences. The trial seeks participants aged 16 to 26 who have been diagnosed with anorexia nervosa and are currently hospitalized for malnutrition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that you cannot have any changes to psychiatric medications for a month before enrolling. Also, you cannot take medications that would be unsafe with ketamine.

Is there any evidence suggesting that ketamine is likely to be safe for humans?

Research has shown that ketamine is generally safe for people. Some studies found that a few individuals might experience mild side effects like nausea, vomiting, or loss of appetite. However, these symptoms are usually not serious, and most people manage them easily. The FDA has already approved ketamine for other uses, indicating it has passed certain safety tests. While no treatment is completely without risk, existing evidence offers some reassurance about ketamine's safety for clinical use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anorexia?

Unlike traditional treatments for anorexia, which often include psychological therapy and medications like antidepressants, ketamine works differently by targeting the brain's glutamate system. Researchers are excited about ketamine because it has shown rapid effects on mood and cognition, potentially offering faster relief from symptoms compared to the weeks or months it can take for other treatments. Additionally, ketamine is administered as an infusion, which allows for precise dosing and fast action, making it a promising new option for those who haven't responded well to existing therapies.

What evidence suggests that ketamine might be an effective treatment for anorexia?

Research has shown that ketamine, administered as an infusion in this trial, can aid individuals with eating disorders such as anorexia. Studies have found that it can improve body weight and facilitate changes in negative thinking patterns. Ketamine is also considered safe for individuals with eating disorders, even if they have other mental health issues. In past studies, patients experienced significant benefits, suggesting ketamine could be a promising treatment for anorexia. ^{6 7 8 9 10}

Who Is on the Research Team?

Amanda E. Downey, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults hospitalized with anorexia nervosa or atypical anorexia. Participants must be medically stable enough to receive a ketamine infusion. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I haven't changed my psychiatric meds in the last month.

I agree to use effective birth control for two weeks after getting ketamine.

I have been diagnosed with anorexia or atypical anorexia.

Exclusion Criteria

Cardiac abnormalities identified on admission

Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial

Active laxative misuse or abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of intravenous (IV) ketamine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in eating disorder symptoms and cognitive flexibility

4 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview

The study tests if a single dose of IV ketamine can help patients with anorexia learn new, positive associations with food by increasing cognitive flexibility, potentially making hospital stays less stressful.

How Is the Trial Designed?

Group I: Ketamine Infusion Experimental Treatment 1 Intervention

Ketamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

Amanda Downey, MD

Lead Sponsor

Trials

1

Recruited

20+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Hypokinesia (restricted movement) in male Wistar rats led to significant increases in potassium (K+) losses and decreases in tissue K+ content, indicating that limited motor activity can negatively impact potassium levels in the body.

Supplementation with potassium chloride during hypokinesia resulted in even greater K+ losses and lower tissue K+ levels compared to unsupplemented rats, suggesting that higher potassium intake may paradoxically increase the risk of tissue depletion during periods of restricted activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium deposition during and after hypokinesia in potassium supplemented and unsupplemented rats. Zorbas, YG., Kakuris, KK., Charapakhin, KP., et al.[2019]

Subcutaneous (SC) administration of racemic ketamine and esketamine has shown rapid and robust antidepressant effects in both unipolar and bipolar patients, with response and remission rates ranging from 50% to 100% after single or multiple doses.

The studies indicated that SC ketamine is generally well-tolerated, with only transitory side effects, making it a promising and cost-effective treatment option for depression, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Ketamine in Depression: A Systematic Review. Cavenaghi, VB., da Costa, LP., Lacerda, ALT., et al.[2021]

Oral ketamine is a potentially safe and effective treatment for depression, but it requires higher doses (2.0-2.5 mg/kg) compared to intravenous administration due to lower systemic absorption (20%-25%).

Despite its promise as a more accessible and affordable option for treatment, the current literature on oral ketamine is limited, and further research is needed to understand its pharmacokinetics, safety, and efficacy compared to other administration routes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Ketamine for Depression, 2: Practical Considerations. Andrade, C.[2020]

In a study involving five participants with eating disorders and comorbid mood and anxiety disorders, weekly group-based ketamine-assisted psychotherapy (G-KAP) over 4 weeks led to significant improvements in depression and anxiety symptoms for most participants, with four showing notable reductions in depression scores and two in anxiety scores.

The ketamine treatment was well tolerated with no serious adverse events reported, indicating its safety and feasibility as an adjunct therapy in intensive residential eating disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of group-based ketamine-assisted psychotherapy for patients in residential treatment for eating disorders with comorbid depression and anxiety disorders. Robison, R., Lafrance, A., Brendle, M., et al.[2022]

An extended release oral ketamine tablet was found to be safe and well tolerated in a study of seven patients with treatment-resistant depression/anxiety, with no significant changes in vital signs and only one brief report of dissociation.

All patients experienced over 50% improvements in mood ratings over 96 hours, suggesting that while the onset of mood improvement is slightly delayed compared to injectable forms, this oral formulation could be a promising option for treating resistant depression and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study. Glue, P., Medlicott, NJ., Neehoff, S., et al.[2022]

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Ketamine as adjuvant treatment in eating disorders

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sciencedirect.com

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Ketamine Treatment is Effective in Treating Restrictive ...

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SAFETY DATA SHEET

VetaKet® (ketamine hydrochloride injection, USP) ... Anorexia, nausea and vomiting have also been observed. Medical Conditions Aggravated by Exposure: Note ...

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May be harmful in contact with skin. May be harmful if inhaled. 4 / 8. Material name: Ketamine Hydrochloride Injection. 255 Version #: 01 Issue ...

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ketamine - accessdata.fda.gov

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Anorexia, nausea and vomiting have also been observed. Aspiration Hazard. None anticipated from normal handling of this product. Dermal ...

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Label: KETALAR- ketamine hydrochloride injection - DailyMed

Eye disorders: Diplopia, nystagmus, elevation in intraocular pressure. Gastrointestinal disorders: Anorexia, nausea, vomiting, hepatobiliary dysfunction.