Supervised use of ketamine, a Schedule III substance, is allowed case-by-case in mental health treatment, although it is not yet approved by the Food and Drug Administration, off-label. What is FDA-approved, however, is esketamine, a close relative of ketamine that has shown promise in treating depression that isn’t responding to the usual treatment methods including therapy and medication. This is not surprising, as there is substantial evidence of ketamine’s therapeutic effects, with early studies linking its use to relief in depression symptoms.

More recently, ketamine is being studied for its therapeutic effects beyond depression. A study published in Ibrain suggests that ketamine could be beneficial in treating post-traumatic stress disorder and depression in patients who have failed to respond to traditional treatments such as talk therapy and psychiatric medications. Animal research, clinical trials, and case reports have shown significant reductions in PTSD-related symptoms and rapid antidepressant effects.

However, the same study also raises concerns over the long-term efficacy and safety of the drug, particularly in light of its effects on the nervous system.

Another recent article published in Missouri Medicine explores the availability of unsupervised and unregulated ketamine treatment through online for-profit companies. The review discusses the dangers of patients self-administering ketamine at home, particularly in the absence of proper medical supervision.

While ketamine’s potential as a treatment for mental illness is undeniable and public interest in alternative therapies for certain conditions is evident, it’s crucial to use caution and evidence-based practices in ensuring patient safety and wellness.

Allie Sharma, M.D., co-founder and chief medical officer at a New York City-based company, addresses the demand for novel treatments for treatment-resistant depression and other mental health conditions. She has looked at what is involved in ketamine infusion therapy and why it is likely to lead a change in how we approach the mental health of those who find traditional methods of treatment ineffective. Here are two important things.

“Treatment-resistant depression is defined as at least two failed medication trials of antidepressants for the current episode of depression,” Sharma explains. “We offer ketamine infusion therapy for treatment-resistant depression, given that ketamine has been shown in numerous studies to provide rapid improvement and durability of response and has the potential to make a long-lasting impact in people’s lives by alleviating the symptoms of depression.”

Sharma's ketamine-based treatment was developed over nearly two years with experts in the fields of anesthesiology and psychiatry. It unfolds through a structured five-step process to ensure the safety, effectiveness, and personalized care for each patient undergoing ketamine infusion therapy. Here’s a breakdown of the process:

This procedural approach ensures that individuals at risk or unlikely to benefit from ketamine are carefully screened out, prioritizing patient safety and the effectiveness of the treatment.

A 2022 narrative review published in the Journal of Pain Research points to ketamine’s beneficial and significant role in reducing symptoms of depression, both initially and over time. Interestingly, it was also found to have improved the psychotherapist-patient relationship, significantly enhancing treatment outcomes.

“KAP refers to a psychotherapy session conducted by a KAP therapist outside—not during or immediately after—the infusion. Therefore, the potential for ethical issues to arise during our KAP sessions is minimized since patients are not in an altered state of consciousness during the KAP sessions.”

This measured approach to therapy involving ketamine is vital as it ensures that therapeutic benefits are maximized while maintaining the highest standards of patient safety and ethical treatment practices.

The FDA’s approval of esketamine, a ketamine derivative, for specific depression cases marks a significant milestone, signaling a shift toward more widespread acceptance of these novel treatments. Another beacon of ketamine’s potential in mental healthcare is that some insurers are starting to offer coverage for certain stages of ketamine infusion therapy, such as initial consultations (for screening) and KAP sessions.

A commitment to safety, through rigorous protocols and expert-led care, exemplifies the responsible advancement in this field. As research continues, particularly in areas like PTSD and alcohol use disorder, and as other novel substances such as MDMA and psilocybin enter clinical trials, regulations are expected to evolve to ensure these therapies’ safe and ethical use. This dynamic interplay between innovation and regulation underscores a hopeful direction for mental health treatment, promising more effective solutions for those grappling with persistent mental health challenges.

A version of this article also appears on Forbes.com.

References

For more on Allie Sharma

QOSHE - 2 Promising Insights From Recent Research on Ketamine - Mark Travers Ph.d
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2 Promising Insights From Recent Research on Ketamine

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29.04.2024

Supervised use of ketamine, a Schedule III substance, is allowed case-by-case in mental health treatment, although it is not yet approved by the Food and Drug Administration, off-label. What is FDA-approved, however, is esketamine, a close relative of ketamine that has shown promise in treating depression that isn’t responding to the usual treatment methods including therapy and medication. This is not surprising, as there is substantial evidence of ketamine’s therapeutic effects, with early studies linking its use to relief in depression symptoms.

More recently, ketamine is being studied for its therapeutic effects beyond depression. A study published in Ibrain suggests that ketamine could be beneficial in treating post-traumatic stress disorder and depression in patients who have failed to respond to traditional treatments such as talk therapy and psychiatric medications. Animal research, clinical trials, and case reports have shown significant reductions in PTSD-related symptoms and rapid antidepressant effects.

However, the same study also raises concerns over the long-term efficacy and safety of the drug, particularly in light of its effects on the nervous system.

Another recent........

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