Largest Study of Psychedelic Medicine, With 11,441 Mindbloom Clients, Demonstrates Effectiveness and Safety of Guided At-home Ketamine Therapy

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Published on 
June 14, 2024
Updated on 

This study corroborates the findings of Mindbloom’s first study over a 10X larger population, and provides new analysis showing the benefits of continued treatment.

Study Overview

The study reviewed data from 11,441 Mindbloom clients, making it the most comprehensive examination of ketamine therapy to date. 

Highlights:

  • Effectiveness: 62% of clients reported clinically-significant improvements in depression or anxiety, and 28% achieved remission 
  • Benefits of Continued Treatment: 84% of clients who experienced significant improvements in an initial program maintained improvements or recovered in a second round of treatment
  • Safety: Fewer than 5% of clients reported side effects
  • Authors: The study was authored by psychiatrists and researchers from Johns Hopkins, NYU Med, The Institute for Psycholinguistics and Digital Health, and Mindbloom
“Millions of Americans are suffering from mental illness, and haven’t been helped by traditional treatments,” said co-author and Mindbloom Medical Director Dr. Leonardo Vando. “This study confirms that at-home ketamine therapy can be an effective and fast-acting treatment for depression and anxiety, and shows why psychedelic therapy is going to be a first-line treatment in the next few years.”

The authors noted that the extensive support offered through Mindbloom – including 1:1 coaching, therapeutic content, and group integration – drives the effectiveness and safety of the treatment. In addition, Mindbloom’s at-home ketamine therapy programs overcome barriers like cost, provider availability, and stigma that prevent people from receiving effective mental health care. 

Key Results

Mindbloom’s at-home ketamine therapy continues to produce stronger outcomes than those shown in studies of antidepressants and psychotherapy.

Symptoms were measured before and after treatment; after 4 sessions, 56% of clients reported 50% or greater reductions in symptoms. When compared to studies of other treatment types, this response rate is:

  • 37% stronger than studies of talk therapy2
  • 19% stronger than studies of SSRI antidepressants3,4
  • 4% stronger than studies of IV ketamine5

The study further revealed that continued treatment extends the benefits:

  • 84% of clients who experienced significant improvements in an initial round of treatment maintained improvements or recovered in a second round
  • 28% of participants who did not experience a significant improvement during their first round of treatment achieved it in a second round 

These findings underscore the potential for ketamine therapy in managing treatment-resistant depression, a condition where people do not respond to at least two different first-line interventions. 

Mindbloom’s programs are remarkably safe.

  • Less than 5% of clients reported any side effects – in contrast up to 50% of patients report side effects when taking antidepressants6
  • Less than 0.5% of clients discontinued treatment due to adverse events
  • Less than 1% of clients experienced worsened symptoms following treatment
“Mindboom’s programs make ketamine therapy accessible and affordable, allowing people to heal from the comfort of home,” said Mindbloom’s Founder and CEO Dylan Beynon. “People have questioned whether ketamine therapy could be delivered safely and effectively at home through telehealth – this study answers that question with an emphatic ‘yes.’”

Leveraging AI Analysis

The study also used artificial intelligence (AI) tools to identify factors that predict whether a patient will respond to treatment, providing clinicians with additional information to support their clients.

Why this study is important

In the face of a persistent and growing mental health crisis, there is an urgent need to increase access to effective treatments:

  • Over 58 million American adults experience mental illness every year.7
  • Less than half of adults with a mental illness receive care, with cost being by far the most cited reason.7
  • Last-generation treatments like SSRIs and psychotherapy aren’t very effective, and ​​~1/3 of people with major depression are treatment-resistant.8
  • Treatment via telehealth can be incredibly effective, less expensive and more convenient than alternatives like IV ketamine.5

The study showed how Mindbloom’s at-home ketamine therapy programs overcome barriers like cost and provider availability that prevent people from accessing care, and provide access to transformational mental health care.

Read the full study in the Journal of Affective Disorders, At-home, telehealth-supported ketamine treatment for depression: Findings from longitudinal, machine learning and symptom network analysis of real-world data 

Want to learn more about at-home ketamine therapy?

References

  1. 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), https://doi.org/10.1016/j.jad.2024.05.131
  2. Cuijpers, P., Karyotaki, E., Ciharova, M., Miguel, C., Noma, H., & Furukawa, T. A. (2021). The effects of psychotherapies for depression on response, remission, reliable change, and deterioration: A meta-analysis. Acta Psychiatrica Scandinavica, 144(3), 288–299. https://doi.org/10.1111/acps.13335 
  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, M. H., Rush, A. J., Wisniewski, S. R., Nierenberg, A. A., Warden, D., Ritz, L., Norquist, G., Howland, R. H., Lebowitz, B., McGrath, P. J., Shores-Wilson, K., Biggs, M. M., Balasubramani, G. K., & Fava, M. (2006). Evaluation of outcomes with citalopram for depression using measurement-based care in star*d: Implications for clinical practice. American Journal of Psychiatry, 163(1), 28–40. https://doi.org/10.1176/appi.ajp.163.1.28
  5. McInnes, L. A., Qian, J. J., Gargeya, R. S., DeBattista, C., & Heifets, B. D. (2022). A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings. Journal of Affective Disorders, 301, 486–495. https://doi.org/10.1016/j.jad.2021.12.097
  6. Braund, T.A., Tillman, G., Palmer, D.M. et al. Antidepressant side effects and their impact on treatment outcome in people with major depressive disorder: an iSPOT-D report. Transl Psychiatry 11, 417 (2021). https://doi.org/10.1038/s41398-021-01533-1
  7. U.S. Department of Health and Human Services. (n.d.). Mental illness. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/mental-illness
  8. Soule, A., & Coughlin, J. (2023, November). Treatment-resistant depression. Johns Hopkins Medicine. https://www.hopkinsmedicine.org/health/conditions-and-diseases/mood-disorders/treatment-resistant-depression
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This article is for informational purposes only and is not intended to be a substitute for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. If you are in a life-threatening situation, call the National Suicide Prevention Line at +1 (800) 273-8255, call 911, or go to the nearest emergency room.

Important FDA Safety Information

Ketamine is not FDA-approved for the treatment of depression or anxiety. Learn more about off-label uses here.

Side effects of ketamine treatment may include: altered sense of time, anxiety, blurred vision, diminished ability to see/hear/feel, dry mouth, elevated blood pressure or heart rate, elevated intraocular or intracranial pressure, excitability, loss of appetite, mental confusion, nausea/vomiting, nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses).

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 reported to produce issues including, but not limited to, those listed below. However, lasting adverse side-effects are rare when medical protocols are carefully followed.

While ketamine has not been shown to be physically addictive, it has been shown to cause moderate psychological dependency in some recreational 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 MindBloom® 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
  • Avoid hangovers or alcohol intake
  • 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 monitor present to ensure your safety