Advancing evidence-based mental health

ORKA (Osmind Real-world Ketamine Analyses)

Osmind Real-world Ketamine Analyses (ORKA) is a series of research studies to assess long-term patient outcomes in large samples of real-world patients undergoing ketamine therapy for depression. In the largest published real-world analysis of ketamine infusion therapy, Osmind teamed up with physician scientists from Stanford University School of Medicine to share findings of ORKA-1 in the Journal of Affective Disorders (March 2022).

The analysis found that ketamine was an effective and durable treatment for depression and that over 70% of patients with suicidal ideation at baseline experienced an overall improvement. ORKA-2 is now underway, once again in collaboration with Heifets Lab faculty researchers at Stanford University, and is assessing the effects of dose, comorbid anxiety and maintenance treatment on depression outcomes. Interim results were presented at the 2022 Ketamine & Related Compounds International Conference at the University of Oxford with a manuscript to come. ORKA-3, which is also in progress, will be shared at a later date.

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.