Leading the way on clinical research

The two largest studies of ketamine therapy followed more than 10,000 Mindbloom clients.
The results speak for themselves.

Journal of Affective Disorders, July 2022

At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression

Journal of Affective Disorders, June 2024

Largest study of psychedelic medicine, with 11,441 Mindbloom clients, demonstrates effectiveness and safety of guided at-home ketamine therapy

01  — at a glance

Almost everyone felt relief.

A third experienced full remission.1,2

At Mindbloom, we don’t just want to offer the very best at-home ketamine experience, we want to help lead the research that is reshaping how we understand mental health treatment. What we’ve seen to date is nothing short of mindblowing: Not only does our at-home ketamine program greatly reduce feelings of anxiety and depression, it does so in hours or days—not months.

Safety information
Important Safety Information

Mindbloom pairs individuals with licensed clinicians who are trained to diagnose and treat anxiety, depression, and other mental health conditions.  If one of the licensed clinicians, in their medical judgment, decides that ketamine is an appropriate treatment for an individual based on a clinical assessment, then the clinician may prescribe ketamine tablets that are compounded by pharmacies under Section 503A of the federal Food, Drug, and Cosmetic Act (FDCA).  Drugs compounded under Section 503A do not require FDA approval, and as such the FDA has not determined that the compounded ketamine prescribed is safe and effective for anxiety, depression, or other mental health conditions.  The use of ketamine for anxiety, depression, and many other mental health conditions, however, is supported by a body of scientific literature.  (Data on file).

Ketamine is a Schedule III controlled substance. Other drugs containing ketamine, which (unlike compounded drugs) are subject to FDA’s approval requirements, have been FDA-approved as an intravenous or intramuscular injection solution for induction and maintenance of general anesthesia. However, those drugs have not been FDA-approved for anxiety, depression, or other mental health conditions, and they have not been FDA-approved in tablet form. The approved label is available here.

Ketamine may cause serious side effects, including but not limited to risks of: sedation; dissociation; psychiatric events or worsening of psychiatric disorders, including problems in people with schizophrenia, severe personality disorders, or other serious mental disorders; dependence, abuse and misuse; anxiety; increases in blood pressure or heart rate; respiratory depression (breathing becomes slower and shallower and the lungs fail to exchange carbon dioxide and oxygen efficiently); lower urinary tract and bladder symptoms, including frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size; altered sense of time; dry mouth; elevated intraocular or intracranial pressure; loss of appetite; confusion; nausea/vomiting; blurred vision; and slurred speech.

The FDA has advised that at-home administration of compounded ketamine may present additional risks because a health care provider is not available onsite to monitor for adverse outcomes resulting from sedation and dissociation.

Mindbloom’s protocols and guidance have been designed to minimize the likelihood of experiencing these side effects or other adverse effects, and should be followed carefully. Ketamine should only be taken as directed by the treating clinician.

Do not proceed with ketamine treatment if any of the following apply to you:

  • Allergic to ketamine
  • Symptoms of psychosis or mania
  • Uncontrolled high blood pressure
  • CHF or other serious heart problem
  • Severe breathing problem
  • History of elevated intraocular or intracranial pressure
  • History of hyperthyroidism
  • Other serious medical illness
  • Pregnant, nursing, or trying to become pregnant

Ketamine has been found to cause moderate psychological dependency in some users.

  • In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
  • Ketamine may worsen problems in people with schizophrenia, severe personality disorders, or other serious mental disorders
  • Users with a personal or family history of psychosis should be cautious using any psychoactive substance, including ketamine, and discuss potential risks with your clinician before proceeding with treatment
  • The dissociative effects of ketamine may increase patient vulnerability and the risk of accidents

To promote positive outcomes and ensure safety, follow these ketamine treatment guidelines:

  • Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep
  • Refrain from taking benzodiazepines or stimulants for 24 hours prior to treatment
  • Continue to take antihypertensive medication as prescribed
  • Do not take ketamine while hungover or with alcoholic beverages
  • Refrain from consuming solid foods within 3 hours prior to treatment and liquids within 1 hour prior to treatment
  • Ketamine treatment should never be conducted without a peer treatment monitor physically present

A peer-reviewed study of Mindbloom’s client treatment outcomes was published in the Journal of Affective Disorders in 2022, titled At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial. The FDA has not evaluated head-to-head trials comparing the safety of ketamine to other medications that are FDA-approved for the treatment of depression, anxiety, or other psychiatric disorders. Although some clients report that they had more success with ketamine than with FDA-approved therapies, these outcomes may not be typical.

For more information about the informed consent that clients review and sign prior to treatment, please visit mindbloom.com/informed-consent.

62%

reported clinically-significant improvements in depression or anxiety2

84%

who experienced significant improvements in an initial program maintained improvements or recovered in a second round of treatment2

95%

reported no side effects from their ketamine treatment with Mindbloom1

28%

who experienced depression and anxiety achieved remission (or virtually no symptoms) after 4 sessions1

Dr. arden on SIDE EFFECTS

It’s not uncommon for traditional treatments such as SSRIs to cause persistent and unpleasant side effects including weight gain, sexual dysfunction, emotional numbness, and digestive issues to name a few which often force people to stop treatment. As ketamine is not taken daily and 50% clears your bloodstream in under 3 hours, most side effects fade same-day. In Mindbloom’s studies, less than 5% reported side effects and only 0.3% stopped treatment because of side effects.

02 — how mindbloom compares

When compared to studies of alternative treatments, Mindbloom’s symptom improvements were stronger—and felt in days, not months.

It was shown that Mindbloom at-home therapy drove significant symptom improvements in depression with outcomes exceeding those seen in studies of traditional therapies3,4,5 and IV ketamine.6   These outcomes are especially promising because of the speed to results. For Mindbloom clients, it took just 4 weeks, while SSRI and psychotherapy studies required 2+ months to achieve reported results.3,4

Psychotherapy5
41
%
SSRI Antidepressants4
47
%
Ketamine Clinics6
54
%
Mindbloom2
56
%

Percent of Patients with >50% Reduction of Depression Symptoms

Dr. arden on WHY THIS MATTERS

With traditional treatments, people might not notice improvements for up to 2 months—that is, if they see improvements at all. Because of ketamine’s fast-acting nature, a number of Mindbloom clients report symptom relief after their very first session, with many experiencing compounding effects after just 4 sessions.

03 — STUDY CO-AUTHORS

Meet some of the top minds behind our research.

Our clinical studies are authored by leaders in the fields of psychology, neuroscience, and psychedelic research, hailing from top institutions such as NYU, UCSF, Lykos (formerly MAPS), and Houston Methodist. Committed to the most rigorous research methodologies, this group is helping us understand the full potential psychedelic treatments can play in addressing mental health conditions.

Teddy J. Akiki, M.D.

Center for Behavioral Health, Neurological Institute, Cleveland Clinic

Adam Gazzaley, M.D., PhD

University of California, San Francisco

Thomas D. Hull, PhD

Institute for Psycholinguistics and Digital Health

Alok Madan, PhD, MPH

Houston Methodist Behavioral Health

Matteo Malgaroli, PhD

Department of Psychiatry, NYU Grossman School of Medicine

David Mathai, MD

Johns Hopkins Center for Psychedelics and Consciousness Research

Casey Paleos, M.D.

Lykos Therapeutics (Formerly MAPS PBC)

Kristin Arden, DNP, APRN, PMHNP-BC

Mindbloom

Leonardo Vando, M.D.

Mindbloom

We believe that the support provided by our clinicians and guides and the comfort of our at-home treatments contribute to the therapy’s effectiveness.”

Leonardo Vando, M.D.
Medical Director, Mindbloom
Science Research

Ketamine research

Clinical research continues to demonstrate that ketamine can be used to treat mental health conditions and their symptoms successfully.

Date
Study
journal
  1. Thomas D. Hull, Matteo Malgaroli, Adam Gazzaley, Teddy J. Akiki, Alok Madan, Leonardo Vando, Kristin Arden, Jack Swain, Madeline Klotz, Casey Paleos,At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial, Journal of Affective Disorders, Volume 314,2022,Pages 59-67,ISSN 0165-0327,https://doi.org/10.1016/j.jad.2022.07.004.

  2. David S. Mathai, Thomas D. Hull, Leonardo Vando, Matteo Malgaroli, At-home, telehealth-supported ketamine treatment for depression: Findings from longitudinal, machine learning and symptom network analysis of real-world data,Journal of Affective Disorders,Volume 361,2024,Pages 198-208,ISSN 0165-0327,https://doi.org/10.1016/j.jad.2024.05.131.

  3. Taliaz, D., Spinrad, A., Barzilay, R. et al. Optimizing prediction of response to antidepressant medications using machine learning and integrated genetic, clinical, and demographic data. Transl Psychiatry 11, 381 (2021). https://doi.org/10.1038/s41398-021-01488-3

  4. Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M; STAR*D Study Team. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006 Jan;163(1):28-40. doi: 10.1176/appi.ajp.163.1.28. PMID: 16390886.

  5. Cuijpers P, Karyotaki E, Ciharova M, Miguel C, Noma H, Furukawa TA. The effects of psychotherapies for depression on response, remission, reliable change, and deterioration: A meta-analysis. Acta Psychiatr Scand. 2021 Sep;144(3):288-299. doi: 10.1111/acps.13335. Epub 2021 Jul 4. PMID: 34107050; PMCID: PMC8457213.

  6. L. Alison McInnes, Jimmy J. Qian, Rishab S. Gargeya, Charles DeBattista, Boris D. Heifets,A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings,Journal of Affective Disorders,Volume 301,2022,Pages 486-495,ISSN 0165-0327,https://doi.org/10.1016/j.jad.2021.12.097.