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First of its kind study to investigate the effects of Almond Therapy in TRD patients receiving intranasal esketamine.
CALGARY, AB, May 10, 2022 /PRNewswire/ – PsiloTec Health Solutions Inc., operating as Zylorion Health, (“Zylorion” or the “Company”), a mental health care and psychedelic therapy focused innovator, is pleased to announce it has received approval from the Health Research Ethics Board of Alberta (the “HREBA”) to conduct a phase II clinical study for patients suffering from treatment-resistant depression (“TRD”).
Approximately 320 million people globally suffer from major depressive disorder (“MDD”). Of this population, roughly one-third do not respond to conventional antidepressants, a condition known as treatment-resistant depression.
The first of its kind, single-blind, randomized, controlled, phase II clinical study will look at clinical outcomes of 102 patients suffering from TRD. The study participants will be observed in two groups. The first group will undergo treatment receiving standard and approved intranasal esketamine (“Spravato”). The second group will undergo treatment receiving both Spravato and Zylorion’s proprietary multi modal therapy, Almond Therapy.
The primary outcome of the clinical study will be to determine if augmentation with Almond Therapy leads to better patient outcomes, as assessed using the Montgomery-Asberg Depression Rating Scale (“MADRS”), a standardized interview measure for depression.
“This marks a very important milestone for Zylorion and for Almond Therapy. While new psychedelic compounds bring hope for the roughly one billion people around the world suffering from mental illness, we strongly believe that these powerful compounds should be administered in combination with appropriate therapy, for both the safety of the patient and to achieve the best clinical and sustainable outcomes,” commented Dr. Peter Silverstone, Chief Executive Officer. “We are committed to taking an evidence-based approach…
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