Segal Trials, a privately held network of research sites throughout South Florida and South Carolina conducting Phase I-IV clinical trials, has been named one of seven sites to initiate a Phase II study of psilocybin—a psychedelic prodrug compound—for major depressive disorder (MDD). Segal Trials holds a Schedule 1 DEA License and will be taking part in Usona Institute’s Phase II PSIL201 study investigating the safety and efficacy of psilocybin for MDD. Usona Institute, founded by Promega Corporation, was inspired by the potential of psilocybin to treat severely depressed patients and alleviate suffering.
The study is a randomized, triple masked, double-blind, support-of-concept Phase II study of single-dose Psilocybin for Major Depressive Disorder. It started October 2019 and will conclude February, 2021. The sponsor, Usona Institute, is targeting 80 participants.
Research sites in addition to Segal Trials include New York University and collaborators include Signant Health (eClinical and service vendor formerly known as Bracket) and The Emmes Company, LLC—a CRO.
Depression: A Crisis
Depression is the leading cause of disability worldwide. The United Nations health agency reported that it affects more than 300 million people worldwide—the majority of them women, young people and the elderly. An estimated 4.4% of the population suffers from depression. The U.S. suffers a crisis in mental health and depression with when combing other social determinants of health lead to severe comorbidities.
Ms. Bonnie Segal, Co-Founder and President of Segal Trials, noted, “Today we are experiencing a depression epidemic, and as part of the medical community it is our duty to help and work alongside pharmaceutical companies to safely test and validate the impacts of new treatments.” Ms. Segal continued, “Psychedelics are one of the oldest substances known to mankind, used to alter mental states. In the world we live in today and with the available medications in the market, we owe it to ourselves and the next generation to be testing, with rigor, new ways to treat depression.”
Who is Segal Clinical?
Founded in 1998, Segal Trials is a privately held network of seven research sites throughout South Florida and South Carolina that conducts Phase I-IV research trials with a primary emphasis on psychiatry, neurology, insomnia and women’s health. The company prides itself on sticking to its core values of quality, customer services, collaboration, advocacy and patient centricity. They report on their website that they have a team of over 120 professionals. To date they have been instrumental in conducting studies resulting in 26 medications that are FDA-approved and are improving the quality of life for millions. Segal Trials offers data management, bioanalytical lab analysis, medical writing, protocol design and review, project management, budget development, and clinical data monitoring services through established vendor relationships and in-house resources. Hence although they are at the core a clinical investigational site they definitely take on characteristics of a contract research organization (CRO).
Segal Trials positions itself as an innovator and lead in the advancement of medicine with a strong dedication to the community it serves by spreading awareness about clinical trials as potential care options. Segal Trials is affiliated with Compass Health Systems, a behavioral health care group practice serving the community since 1990.
Ms. Bonny Segal co-founded Segal Trials after successful start-up and acquisitions with other health service ventures including Positive Aging, a company specializing in psychiatric services for individuals residing in long-term care facilities. She also founded and sold Essentials in Psychology prior to forming Segal Trials. Ms. Segal has helped drive participation in over 1,000 clinical trials associated with all seven Segal Trials site locations according to her bio.
With 29 research beds, a centralized nursing station, lab processing area, and pharmacy, in addition to amenities such as recreational area, an outdoor monitored courtyard, retention tools, secured access and alarmed doors, televisions in every room, monitored wi-fi, and internet access, with the ability with the ability to segregate populations by wing. It is staffed by a team of experienced professional and robust support team offering quality control, patient recruitment support, operational expertise and private transportation to ensure the highest quality of services offered to clients.
They employ about 100 professionals at their various sites.
They include roles such as “Start Up Director” for efficient and effective services to sponsor clients who need expedited study start up, for example. Their Director of Clinical Operations, Erin Tireman, has been there for a decade.
Contribution to Success
Segal Trials, founded in 1998, reports that the privately held network of over seven research sites has contributed to studies that have led to 26 approved FDA medicines. They emphasize some prominent alliances and associations in the industry.
TrialSite News couldn’t find any adverse any FDA findings based on inspections. Moreover, a review of their Facebook sites included overwhelmingly positive reviews—and we can’t say this for every clinical investigational site we review.
Who is the Sponsor? Usona Institute
Usona Institute, a non-profit medical research organization, they are dedicated to supporting and conducting pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Their mission centers on the alleviating of depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.
They appear to employ under 25 and were founded in 2014 by Bill Linton, the founder of the international life sciences company Promega Corporation as well as Malynn Utzinger, MD, Director of Integrative Practices at Promega Corporation. The institute was formed after Bill was inspired by a meaningful impact a study at Johns Hopkins had on a friend suffering from cancer. Their research focuses on depression.
Segal Trials will support this study along with New York University.
Call to Action: This is an incredibly interesting topic—the application of psilocybin as a potential treatment for major depression. TrialSite News will be monitoring this study carefully.