The Single-Arm Studies Will Be Focused on Treatment-Resistant Depression and Post-Traumatic Stress Disorder
VANCOUVER, British Columbia, Oct. 14, 2021 (GLOBE NEWSWIRE) -- KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, is pleased to announce that it will be launching a single arm, open label study of patients with post-traumatic stress disorder (“PTSD”) who are undergoing the proprietary physical therapy program at the Company’s IRP Health clinics (the “PTSD Study”) as well as an observational, single-arm, pilot study aimed at collecting objective biometric data and validated psychiatric instrument measures of efficacy in patients with depression symptoms who are receiving IV ketamine infusion therapy (the “Depression Study”) (collectively, the “Research Studies”). The Research Studies will be conducted across multiple Ketamine One clinic locations in Canada and the United States and are both expected to begin in the month of November.
The PTSD Study is designed to occur over the twelve weeks of IRP Health’s physical therapy program, which includes exercise therapy, physiotherapy and pain neurophysiology education. The participants, most of whom are veterans and first responders, will be adults with PTSD who are also experiencing some form of pain that is musculoskeletal in origin. The program is meant to alleviate both pain and PTSD symptoms over the study period. The PTSD study will be observational in nature and will gather symptom data using validated patient reported questionnaires as well as objective sleep and biometric data. The protocol and information consent form (“ICF”) for the PTSD Study have been submitted to the Institutional Review Board (“IRB”) and are currently under review. Ketamine One’s wholly owned subsidiary, KGK Science Inc., will lead the study, including building the database and conducting training, among other tasks.
The protocol and ICF for the Depression Study are currently being finalized and is expected to be submitted to the IRB in the near future. The trial is expected to begin in late November, subject to the operational capacity of the Company’s medical clinics. The purpose of the Depression Study is to investigate ketamine as a fast-onset treatment for depression given that the duration of the relief from symptoms varies in patients with most requiring a booster within 4-6 weeks. Specifically, there is currently no way for physicians to predict a relapse, therefore patients may fully relapse before they are able to receive a booster dose. The Depression Study will look to correlate the efficacy of treatments with objective measures that have been suggested in the past to be predictive of efficacy. Its aim is to identify patterns in the data that are predictive of relapse and may be used to inform the development of an algorithm to determine the optimal timing for physicians to administer booster doses of ketamine to patients based on their objective biometric data.
“The launch of these inaugural studies by Ketamine One is a great milestone for our Company and a clear demonstration of the synergies being created between the subsidiaries of KGK Science and IRP Health. These studies represent full collaboration between all our divisions - KGK, IRP Health and our ketamine clinic network. Our mental health platform is enabling us to explore important topics and seek to find the answers to long-standing questions about the efficacy of IV ketamine treatments and how to improve treatment outcomes,” said Adam Deffett, Interim CEO of Ketamine One. “Our hope is that both the PTSD Study and the Depression Study yield significant results, which enable not only our clinicians but those in other clinics as well as to improve the patient experience and alleviate chronic pain, depression and other interrelated issues,” added Mr. Deffett.
ABOUT KETAMINE ONE
KetamineOne Capital Limited is a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments. It is working to provide the critical infrastructure needed to develop and deliver breakthrough mental health treatments. Ketamine One has a network of clinics across North America, with plans to further consolidate the highly fragmented industry. KGK Science Inc., the Company’s wholly owned, contract research division also places the company at the forefront of premium clinical research based on its long history and extensive experience in pharmaceuticals, cannabis, and the emerging psychedelic medicine industries. As a collective enterprise, Ketamine One is dedicated to helping solve the growing need for safe and accessible mental health therapy.
On behalf of:
Adam Deffett, Interim CEO
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