Condition: Depressive Disorder, Major · Sponsor: Usona Institute
Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| University of Alabama Clinical Research Unit | Birmingham, Alabama, United States | — |
| Preferred Research Partners-NWA, LLC | Fayetteville, Arkansas, United States | — |
| Preferred Research Partners, Inc. | Little Rock, Arkansas, United States | — |
| Kadima Neuropsychiatry Institute | La Jolla, California, United States | — |
| West LA VA Medical Center - Mental Health Department | Los Angeles, California, United States | — |
| Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners | Santa Monica, California, United States | — |
| Psychedelic Science Institute | Santa Monica, California, United States | — |
| Mountain View Clinical Research | Denver, Colorado, United States | — |
| Connecticut Mental Health Center, Yale University | New Haven, Connecticut, United States | — |
| Clinical Neuroscience Solutions Inc. | Jacksonville, Florida, United States | — |
| Innovative Clinical Research, Inc. | Lauderhill, Florida, United States | — |
| Clinical Neuroscience Solutions, Inc. | Orlando, Florida, United States | — |
+ 17 more locations — full list on the registry record.
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