Braxia Scientific Corp has reported encouraging preliminary findings of a recent clinical study that suggests ketamine may be as effective as a standalone antidepressant, versus as an adjunctive therapy.
The Toronto-based company said the study showed comparable clinical benefits such as antidepressant effects and reduction in suicidal thoughts in a large sample of 220 patients with treatment-resistant depression (TRD) who received intravenous ketamine infusions as a monotherapy, as compared with those receiving ketamine in addition to oral antidepressants.
The study was conducted at the Canadian Rapid Treatment Centre of Excellence, a wholly-owned Braxia subsidiary.
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Following the study protocols, participants in the ketamine monotherapy group achieved response and remission rates of 39.1% and 17.4%, respectively. Meanwhile, those receiving ketamine treatment adjunct to antidepressants saw corresponding rates of 21.9% and 6.7%.
"We continue to inform and refine treatment protocols on the implementation of ketamine for individuals with TRD," Braxia Scientific CEO Dr Roger McIntyre said in a statement.
"In many circumstances, persons who safely benefited from ketamine treatment were able to discontinue their ineffective conventional treatments and transition entirely to ketamine monotherapy. Additionally, this data further informs Braxia Scientific's drug discovery and development, especially as it relates to the appropriate patient selection and enrolment for our clinical research studies,” he added.
The company said ketamine has been shown to provide rapid and significant antidepressant effects in individuals with unipolar and bipolar TRD, and can also rapidly reduce suicidal thoughts.
"While these findings are preliminary, they support the idea that ketamine is a highly effective rapid-acting antidepressant treatment approach as evidenced by its ability to improve depression as a monotherapy,” chief medical and scientific officer Dr Joshua Rosenblat said.
“This data is particularly important because it shows that the benefits of ketamine may not be dependent on the co-prescription of other medications."
According to the study, "Ketamine has been almost exclusively studied as an antidepressant adjunct to other antidepressants. Due to the dearth of high-quality clinical data on the safety and efficacy of ketamine as an antidepressant monotherapy, the majority of clinicians continue to prescribe ketamine to patients with the condition that they remain on a stable dose of one or more antidepressant drugs for the duration of treatment."
"The study provides real-world evidence, from a large sample of persons treatment-seeking for TRD, that further advances the science and substantiates our research that ketamine is a safe, effective and rapid-acting treatment for depression, suicidality and other brain-based disorders,” Rosenblat concluded.
Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders.
Contact the author at stephen.gunnion@proactiveinvestors.com