KetamineOne Capital Limited (LSE:CAPD) has announced that it will launch a single-arm, open-label study of patients with post-traumatic stress disorder (PTSD) who are undergoing its proprietary physical therapy program at its IRP Health clinics 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 symptoms of depression who are receiving IV ketamine infusion therapy.
The Vancouver, British Columbia-based company said the research studies will be conducted across multiple Ketamine One (NEO:MEDI.AQN) clinic locations in Canada and the US and are both expected to begin in November.
“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,” Ketamine One interim CEO Adam Deffett said in a statement.
“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,” he added.
READ: Ketamine One subsidiary KGK Science contracted to support a ketamine clinical trial in the US
The company noted that the launch of the inaugural studies is a great milestone and a clear demonstration of the synergies being created between subsidiaries KGK Science and IRP Health.
“These studies represent full collaboration between all our divisions - KGK, IRP Health and our ketamine clinic network,” Deffett said.
KSK Science will lead the PTSD Study, which 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, with the program aimed at alleviating both pain and PTSD symptoms over the study period.
The PTSD Study will be observational 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 and are currently under review.
KetamineOne said 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 relapse, therefore patients may fully relapse before they can receive a booster dose, the company added.
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. It aims 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 company said the protocol and ICF for the Depression Study are currently being finalized and are expected to be submitted to the IRB soon. The trial is expected to begin in late November, subject to the operational capacity of its clinics.
Ketamine One is focused on consolidating medical clinics and becoming a North American leader in mental health treatments. The recent addition of KGK Science Inc. as the company’s contract research division also places the company at the forefront of clinical research based on its 24-year history and experience in pharmaceuticals, cannabis, and emerging psychedelic medicine industries.
Contact the author at stephen.gunnion@proactiveinvestors.com