Psilocybin Labeled "Breakthrough" Treatment
From "FDA Calls Psychedelic Psilocybin a 'Breakthrough Therapy' for Severe Depression" -by Yasemin Saplakoglu
"The FDA is helping to speed up the process of researching and approving psilocybin, a hallucinogenic substance in magic mushrooms, to treat major depressive disorder (MDD).
For the second time in a year, the U.S. Food and Drug Administration (FDA) has designated psilocybin therapy — currently being tested in clinical trials — as "breakthrough therapy," an action that is meant to accelerate the typically sluggish process of drug development and review. It is typically requested by a drug company and granted only when preliminary evidence suggests the drug may be an enormous improvement over already available therapy, according to the FDA.
Last year, the FDA granted "breakthrough therapy" status to psilocybin therapy in the still-ongoing clinical trials run by the company Compass Pathways, which are looking into psilocybin's potential to treat severe treatment-resistant depression, or depression in patients who have not improved after undergoing two different antidepressant treatments, according to New Atlas.
Now, the FDA has granted another "breakthrough therapy" status to the psychedelic treatment, this time for a U.S.-based clinical trial conducted by the nonprofit Usona Institute, according to a statement from the company. This clinical trial, which includes 80 participants at seven different sites across the U.S., focuses on the efficacy of treating patients with MDD with a single dose of psilocybin.
There are more than 17 million people in the U.S. who have major depressive disorder, or severe depression that lasts more than two weeks, according to the statement. Psilocybin, with a single dose, could profoundly impact the brain and have long-lasting impacts after wiping away depressive symptoms, according to the statement.
The phase 2 trial is expected to be completed by early 2021, and with the help of this status, Usona expects it to quickly move into a larger phase 3 trial, according to New Atlas. Around one in three treatments previously given a Breakthrough Therapy status have moved on to get market approval, New Atlas wrote.
"What is truly groundbreaking is FDA's rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies," Dr. Charles Raison, the director of clinical and translational research at Usona, said in the statement.
This isn't the first time that a psychedelic has been researched for its potential in treating depression. In March, the FDA approved a nasal spray depression treatment for treatment-resistant patients based on Esketamine, a substance related to ketamine — an anesthetic that's also been used as an illicit party drug. But much is still unknown even of this approved drug. Though fast-acting, it's unclear how Esketamine changes the brain and thus what its long-term effects will be, according to a previous Live Science report."
Saplakoglu, Y. (2019, November 25). FDA calls Psychedelic Psilocybin a 'breakthrough THERAPY' for severe depression. LiveScience. Retrieved from https://www.livescience.com/psilocybin-depression-breakthrough-therapy.html.
Psilocybin Therapies and Research
Psilocybin Science and Therapies
- Study: Psilocybin enhances therapy in patients with major depression
Patients with major depressive disorder who received two administrations of the psychedelic psilocybin as part of a psychotherapy regimen saw a rapid and lasting improvement in depression symptoms, a randomized open‐label trial has found. These findings extend results of research that have suggested antidepressant effects for psilocybin in patients with cancer and treatment‐resistant depression, the researchers stated. - Participant Reports of Mindfulness, Posttraumatic Growth, and Social Connectedness in Psilocybin-Assisted Group Therapy: An Interpretive Phenomenological Analysis
The primary objective of this qualitative study was to explore the therapeutic trajectories of individuals undergoing psilocybin-assisted group therapy. This interpretive phenomenological analysis focused on an enriched study sample of gay-identified cisgender men ( n = 9) with human immunodeficiency virus diagnosed before 1996 and clinically significant trauma symptoms. Microphenomenological interviews were carried out 1 day after participants’ individual psilocybin sessions to elicit fine-grained descriptions of the psilocybin-assisted treatment. Two major thematic change processes were identified using Interpretive Phenomenological Analysis. During their psilocybin sessions, participants reported transitioning out of habitual, evaluative modes of processing and into mindful, experiential modes of processing (from “autopilot” to “meta-aware”). Freed from their emotionally avoidant tendencies, participants were able to process and release previously disowned feelings (grief, shame) and access relational and self-transcendent feelings and prosocial attitudes (joy, gratitude, love, care, compassion). The treatment also supported processes of meaning-making and the realization of posttraumatic growth (in psychological, relational, spiritual dimensions) as participants integrated past traumas into their life narratives and identities (from “trauma-dominant” to “growth-dominant”). These findings suggest that administering adjunctive group therapy with psilocybin may enhance the effectiveness of trauma processing by reinforcing social cohesion, safety, trust, and belonging. These data provide the first empirical suggestion of psilocybin’s efficacy in alleviating trauma symptoms in a group-facilitated format and provide a deeper understanding of the potential psychological change processes involved in this novel treatment approach. - Depression, Mindfulness, and Psilocybin: Possible Complementary Effects of Mindfulness Meditation and Psilocybin in the Treatment of Depression. A Review
Depression is a major public health problem that affects approximately 4.4% of the global population. Since conventional pharmacotherapies and psychotherapies are only partially effective, as demonstrated by the number of patients failing to achieve remission, alternative treatments are needed. Mindfulness meditation (MM) and psilocybin represent two promising novel treatments that might even have complementary therapeutic effects when combined. Since the current literature is limited to theoretical and empirical underpinnings of either treatment alone, the present review aimed to identify possible complementary effects that may be relevant to the treatment of depression. To that end, the individual effects of MM and psilocybin, and their underlying working mechanisms, were compared on a non-exhaustive selection of six prominent psychological and biological processes that are well known to show impairments in patients suffering from major depression disorder, that is mood, executive functioning, social skills, neuroplasticity, core neural networks, and neuroendocrine and neuroimmunological levels. Based on predefined search strings used in two online databases (PubMed and Google Scholar) 1129 articles were identified. After screening title and abstract for relevance related to the question, 82 articles were retained and 11 were added after reference list search, resulting in 93 articles included in the review. Findings show that MM and psilocybin exert similar effects on mood, social skills, and neuroplasticity; different effects were found on executive functioning, neural core networks, and neuroendocrine and neuroimmune system markers. Potential mechanisms of MM's effects are enhanced affective self-regulation through mental strategies, optimization of stress reactivity, and structural and functional adjustments of prefrontal and limbic areas; psilocybin's effects might be established attenuation of cognitive associations through deep personal insights, cognitive disinhibition, and global neural network disintegration. It is suggested that, when used in combination, MM and psilocybin could exert complementary effects by potentiating or prolonging mutual positive effects, for example, MM potentially facilitating psilocybin-induced peak experiences. Future placebo-controlled double-blind randomized trials focusing on psilocybin-assisted mindfulness-based therapy will provide knowledge about whether the proposed combination of therapies maximizes their efficacy in the treatment of depression or depressive symptomatology.
Psilocybin Trials in Chicagoland
Psilocybin Trials in Chicagoland
In 2013 Bill Linton and Malynn Utzinger began to discuss their shared interest in research exploring psilocybin as a potential treatment for psychological distress. The results of previous studies were inspiring, but a lot of work was still necessary to move this important research forward. In 2014, Usona Institute became a non-profit with the ultimate goal of shepherding psilocybin research through the necessary phases of clinical trials so that the FDA can thoroughly evaluate it as a possible prescribed treatment for depression.
Research to Alleviate Suffering
Depression is a health crisis of epidemic proportions. According to the World Health Organization, it is the leading cause of disability in the world. There is an urgent need to identify and test novel treatments that may benefit people suffering from depression.
Usona is striving to answer that need.
As part of our mission to alleviate mental suffering, we are exploring the therapeutic potential of consciousness‑expanding medicines like psilocybin.
World‑renowned experts guide us, with internal and collaborative expertise in the fields of mental health and psilocybin research. We are currently developing research studies focusing on psilocybin as a treatment for depression.
Website: https://usonaclinicaltrials.org/major-depressive-disorder-psilocybin-clinical-trial-psil201
