Over the years, Segal Trials has grown into one of the premier, privately held clinical trial sites in the U.S., with six sites located in South Florida and Charleston, South Carolina focusing on mental health and women’s health; and has been awarded groundbreaking studies such as the use of Psilocybin as a treatment for MDD in the study PSIL201 (ClinicalTrials.gov Identifier: NCT03866174).
Segal Trials, a privately held network of research sites throughout South Florida and South Carolina conducting Phase I-IV trials, is excited to announce the screening of its first patient for a Phase 2 clinical trial (Usona PSIL201) investigating the safety and efficacy of psilocybin for major depressive disorder (MDD).
Dr. Rishi Kakar and his clinical research team, at Segal Trials, at our West Broward Outpatient site will be spearheading this trial for the organization. The Usona study will use a randomized, double-blinded, placebo-controlled design to evaluate the potential antidepressant effects of a single dose of psilocybin in patients with MDD.
“Earlier studies of psilocybin and MDD are very encouraging where psilocybin seems to exert effect by a novel fast acting mechanism. I’m very excited to Investigate psilocybin in a clinical trial setting.”Dr. Rishi Kakar
The Usona Institute received Breakthrough Therapy Designation from the FDA for the use of psilocybin in the treatment of major depressive disorder. There are over 17 million people in the United States who suffer from major depression, and this breakthrough designation is important as it addresses an unmet need and offers another option that may allow a clinically significant improvement over other therapies on the market.
Data suggest that psilocybin may have behavioral effects relevant to the treatment of depression and recent studies also suggest that psilocybin may possess antidepressant properties. To further assess the effects of psilocybin on MDD signs and symptoms, this trial will assess the safety and efficacy of psilocybin on 80 individuals suffering from MDD at seven sites within the US. Dr. Kakar, of Segal Trials, is proud to be one of these sites, exploring this new breakthrough treatment for depression.
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