Osmind Real-world Ketamine Analyses (ORKA)

As a Public Benefit Corporation, it is our mission to foster the development of new, effective treatments for moderate to severe mental health conditions, and to help ensure robust access to care for patients of all backgrounds. One way we work towards these goals is to advance science and clinical care through research studies and real-world evidence. ORKA (Osmind Real-world Ketamine Analyses) is a series of research studies that assess long-term patient outcomes in large samples of real-world patients undergoing ketamine therapy for depression.

The goal of ORKA is to understand the efficacy and safety of ketamine therapy as it is practiced in the community, versus the more limited scope of clinical trials. Clinical trials can only assess a specific combination of controlled parameters, whereas in the real world a variety of treatment regimens and patient characteristics intersect. It is additionally unclear how patients enrolled in prospective, randomized trials (usually in academic medical centers) compare to those seeking care in private practice. As the majority of patients receiving ketamine are treated in community practices, it is crucial to assess outcomes in these settings. Such real-world evidence is critical to establish the safety and efficacy of new treatments for patients and to obtain the necessary support of payers to ensure broad access to care.

ORKA-1

Completed.

Published peer-reviewed article “A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings” in the Journal of Affective Disorders.

See below for details.

ORKA-2

In progress.

In conjunction with some of the pioneers of ketamine therapy and leading academic partners, we are retrospectively analyzing ketamine outcomes across thousands of patients treated in community practice from 2017-2020. This study, which examines a separate patient population from ORKA-1, will supplement our published work with a larger sample size, more standardized treatment protocol, and deeper demographic data. As part of ORKA-2 we may also examine data from 2011-2017. Email us at research@osmind.org for more information.

ORKA-1

ORKA-1 is the largest real-world analysis of ketamine intravenous therapy (KIT) outcomes in a community sample to date. Our work was published in the Journal of Affective Disorders as a peer-reviewed research article titled “A retrospective analysis of ketamine intravenous therapy for depression in real-world care settings.” Our paper follows a large body of significant ketamine studies that have been published in this journal over the past few years. We completed ORKA-1 in conjunction with leading physician-scientists at Stanford University School of Medicine.

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.

Summary of main findings

Overview

We analyzed ketamine infusion therapy (KIT) outcomes in a subset of 537 depressed patients (out of 9016 patients) between 2016 to 2020 at one of 178 community practices across the United States. This is the largest published real-world analysis of KIT outcomes in a community sample to date. Data was collected through a measurement-based care tool.

Induction

Maintenance and relapse

Key takeaways

1. KIT is a rapid and robust treatment for depression.

2. The response to KIT is also relatively durable, even in the absence of maintenance treatments.

Significance of the study for ketamine clinicians

Clinical

Administrative / business

"This study alone presents data on more patients than have ever been studied in clinical trials of IV ketamine and underscores the importance of real-world evidence (RWE), especially for the use of off-label medications like ketamine. Clinical trials enroll relatively small numbers of carefully screened patients that may not represent the patients you will see in your practice. RWE furthers the preliminary understanding that we gain from clinical trials to establish the safety and efficacy of treatment interventions in the general population. For example, it will certainly be less expensive for insurers to reimburse for ketamine than for TMS and the two treatments appear to have at least comparable efficacy. Osmind is already working on follow up studies with fuller demographic and clinical data on patients to assess longer term ketamine outcomes and safety."

- Alison McInnes, MD, MS
Lead author of the paper and VP Medical Affairs at Osmind
"Ketamine therapy for depression is rapidly changing the face of mental health care in the US. The truth is, the need for relief has far outstripped the academic community's ability to generate high quality prospective data on the ever-expanding variety of real world therapeutic practices involving ketamine. The innovation is now happening in the field — our study is the largest of its kind to capture a snapshot of what real-world ketamine clinics are doing, and how their patients fare. I’m thrilled to have teamed up with Osmind to take a first look at such a large set of real-world outcomes, and I'm looking forward to digging deeper into what works, and for whom."

- Boris Heifets, MD, PhD
Senior author of the paper; professor, physician, and neuroscientist at Stanford

"RWE data collection is taking off in the ketamine space, and it's clear Osmind are field leaders here. I look forward to seeing RWE initiatives being utilised when MDMA and psilocybin therapy become available for patients. It will be essential for assessing their relative merits versus already existing treatment options, including KIT."

- Robin Carhart-Harris, PhD
Ralph Metzner Distinguished Professor of Neurology and Psychiatry and Founding Director of the Neuroscape Psychedelics Division at UCSF
"The data from this new, retrospective analysis of ketamine infusion therapy by Osmind provides real world evidence that ketamine reduces suicidal ideation and depression. This study is also one of the first analyses to show the durability of the effects of ketamine over time. This coincides with what we have been observing in the real world from applied usage. This study provides real world evidence that ketamine infusion therapy is life changing and should be accessible for all patients through insurance coverage."

- Kimberly Juroviesky, WHNP, CNM
President of The Ketamine Taskforce for Access to Safe Care and Insurance Coverage
"The pandemic has accelerated the need for real-world research and new, effective treatments that address the global burden of mental health disease. Osmind's first real-world ketamine study underscores the commitment this team has made as a Public Benefit Corporation to operating on principles of social justice and inclusivity, and ensuring robust access to care for patients of all backgrounds."

- Steve Jurvetson
Prominent philanthropist supporting psychedelic science (e.g. the Psychedelic Science Funders Collaborative); Co-founder of Future Ventures and DFJ

Collaborate with us

We regularly work with clinicians and researchers on a variety of exciting research projects to generate new clinical insights that can help people. As a Public Benefit Corporation, we look forward to making more meaningful and transformative contributions to the clinical and patient community. Please email research@osmind.org to learn more about ways we can work together.
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