Comment from Anonymous

I am writing in response to the FDA's call for public comment on drug repurposing for unmet medical needs. I am a licensed psychotherapist (LCSW) who has treated patients with depression for 6 years, and I would like to share my clinical experience regarding IV ketamine treatment for depression. I am also a patient myself, and have personally experienced the benefits of using IV ketamine treatment for my own depression, as well as the barriers to affordable treatment. I first experienced a reduction in lifelong, treatment-resistant depression after IV ketamine treatment in 2020, the same year I became a psychotherapist. I had tried many medications and was engaged in my own therapy, but nothing reduced my symptoms as much as that first round of ketamine treatment. These days, I do IV ketamine about once a year as my only treatment for depression, and it has been truly life changing. It has allowed me to live a more productive, meaningful life, has deepened my relationships, and has made me a better therapist. My personal experience with depression and ketamine coincided with my training as a therapist. I have completed training in Ketamine Assisted Psychotherapy, and have referred a number of patients for IV ketamine treatment when traditional approaches failed to provide adequate relief. Many of these individuals had previously tried multiple antidepressants, psychotherapy, and other interventions without achieving meaningful improvement. The outcomes I have observed have been remarkable, similar to my own. Patients who had been depressed for years reported substantial reductions in symptoms, had increased engagement in therapy, improved relationships, and renewed participation in work and family life. In several cases, improvements occurred after other evidence-based interventions had been exhausted. I have also observed that IV ketamine treatment is delivered within a highly structured medical setting with appropriate clinical monitoring and coordination between providers. My experience working alongside ketamine treatment providers has reinforced my confidence in the safety and professionalism of this model of care. Given the extensive study of IV ketamine's efficacy in treating depression paired with my own clinical and personal experience, it is my opinion that ketamine should be considered as a first line of treatment for depression. Despite these benefits, many of my patients, and I myself, have faced significant financial barriers to treatment because IV ketamine remains an off-label intervention for depression, and thus not covered by most insurance plans. This leads to delayed treatment, reduced frequency of recommended maintenance care, or discontinuation of treatment altogether due to cost. Based on my personal AND clinical experience, IV ketamine addresses a significant unmet need for patients with treatment-resistant depression. An FDA-approved indication for depression would help expand access to a treatment that has provided meaningful benefit to many patients who did not respond to conventional therapies. We are facing a mental health crisis in our country, and ketamine has been proven time and time again to be one of the safest and most effective treatments for depression in history. We should make it accessible and affordable for all who might benefit from it. Thank you for considering my perspective and experience.