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Largest-ever ketamine therapy study shows safety, efficacy of at-home treatment; outcomes far exceed those of traditional antidepressant studies

Mindbloom is announcing the largest-ever study of ketamine therapy (1,247 participants), showing that at-home programs can improve symptoms of depression and anxiety with minimal side effects.1

This study will be published in a top-tier, peer-reviewed psychiatry journal, the Journal of Affective Disorders, on October 1, 2022 and is 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.”

Findings at-a-glance

  • The largest study of ketamine therapy has been peer-reviewed and will be published in the Journal of Affective Disorders.
  • 89% of the participants reported improvement in their depression or anxiety symptoms, and 63% of participants experienced a greater than 50% reduction.
  • For both depression and anxiety, over 30% achieved remission (or virtually no symptoms) after 4 sessions.
  • 62% of participants who reported suicidal ideation at baseline no longer reported any suicidal ideation after 4 sessions.
  • Depression response rates were significantly higher than those seen in studies of traditional treatments, such as antidepressants,2,3 talk therapy.4 and also higher than those reported for IV ketamine5.
  • Fewer than 5% of participants reported side effects from treatment.
  • These findings show that at-home ketamine therapy can be a safe and effective option for managing mental health.

“This landmark study showed outcomes for at-home ketamine therapy that far exceeded those of traditional depression treatments,” says Mindbloom Medical Director Dr. Leonardo Vando. “This therapy compares very favorably against studies on traditional treatments such as antidepressants and talk therapy. We believe that the support provided by our clinicians and guides and the comfort of our at-home, needle-free treatments contribute to the therapy’s effectiveness.”

Why this study is important

The United States continues to experience a growing mental health care crisis:

  • Anxiety and depression are a leading cause of disability in the United States, and almost half of adults will have a mental illness in their lifetime.6
  • Over 60% of adults with a mental illness don't receive care, with cost being by far the most cited reason.7
  • Further, ​​1/3 of people with major depression are treatment resistant.8

This growing epidemic is currently outpacing the number of clinicians available to provide care.9 By raising awareness and increasing access to at-home therapies like Mindbloom, we can reach more people in need and give people more tools to manage their mental health.

Here are the study’s key results…

At-home ketamine therapy with Mindbloom produced stronger outcomes than those cited in other studies of antidepressants and psychotherapy

Participants’ symptoms were measured before and after treatment, and after 4 sessions:

  • 89% reported an improvement in symptoms 
  • 63% reported a 50% or greater reduction in symptoms
  • 33% achieved remission (or virtually no symptoms)

When compared to studies of traditional therapies2,3,4 and IV ketamine,5 at-home ketamine therapy produced a greater improvement in symptoms.

  • 34% higher than those of SSRI antidepressants,3
  • 54% higher than those of psychotherapy4
  • 17% higher than those seen in IV ketamine —despite Mindbloom’s less invasive and lower-cost at-home treatments5
  • Mindbloom’s study reported these outcomes after 4 weeks, while SSRI and psychotherapy studies required 2+ months to achieve reported results3,4

Study indicates safety of at-home treatment

The study showed that at-home ketamine therapy was not only effective but safe, with minimal side effects or adverse events reported by participants.

  • Fewer than 1% of the study’s participants’ experienced worsening of symptoms over the course of the study.
  • Fewer than 5% of participants reported any side effects.
  • Only 4 patients (0.3%) dropped out of treatment due to adverse events or intolerable side effects.

At-home ketamine therapy also provided remission from suicidal ideation

The at-home ketamine therapy modality brings hope to those who’ve lived with major mental health symptoms including thoughts of self-harm and suicide. 

  • 62% of patients who reported suicidal ideation at baseline no longer reported any suicidal ideation after 4 sessions.
  • Suicide ideation (SI) was defined as a score >0 on PHQ item 9. Of the 295 participants who reported SI baseline, 67 reported SI after 4 sessions and 119 did not complete the assessment.

“The results of this study make it clear that ketamine therapy is the future of mental healthcare,” says Mindbloom Founder and CEO Dylan Beynon. “This groundbreaking study is an opportunity to dispel common misconceptions about ketamine therapy, and to help us bring its healing power to more people than ever before.” 

The study was written by physicians and researchers from the psychiatry departments of Cleveland Clinic, UCSF, NYU, and Houston Methodist. Its Senior Author is Principal Investigator for the MAPS Phase 3 MDMA-assisted therapy for PTSD clinical trial. 

Read the full study here, “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

Want to learn more about at-home ketamine therapy?

  • For safety information about ketamine, click here.

References:

1. Hull, T. D., Malgaroli, M., Gazzaley, A., Akiki, T. J., Madan, A., Vando, L., Arden, K., Swain, J., Klotz, M., & Paleos, C. (2022). 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, 314, 59–67. https://doi.org/10.1016/j.jad.2022.07.004 

2. 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

3. 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 

4. 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 

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. Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/

7. Bringing behavioral health into the care continuum: Opportunities to improve quality, costs and outcomes: AHA. American Hospital Association. (n.d.). Retrieved July 14, 2022, from https://www.aha.org/guidesreports/2012-01-20-bringing-behavioral-health-care-continuum-opportunities-improve-quality 

8. Brown, J. (2020, February 3). 4 things we now know about treatment-resistant depression. Content Lab U.S. Retrieved July 14, 2022, from https://www.jnj.com/health-and-wellness/4-facts-about-treatment-resistant-depression 

9. Hoge, M. A., Stuart, G. W., Morris, J. A., Huey, L. Y., Flaherty, M. T., & Paris Jr., M. (2019). Behavioral Health Workforce Development in the United States. Substance Abuse and Addiction, 433–455. https://doi.org/10.4018/978-1-5225-7666-2.ch023

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Disclaimer

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

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Largest-ever ketamine therapy study shows safety, efficacy of at-home treatment; outcomes far exceed those of traditional antidepressant studies