The Promise of Therapeutic Psilocybin: An Evaluation of the 134 Clinical Trials, 54 Potential Indications, and 0 Marketing Approvals on ClinicalTrials.gov
Drug Design Development and Therapy – April 01, 2024
Source: OpenAlex
Summary
Hundreds of psilocybin clinical trials over two decades are paradoxically hindering its medical approval. Current psychedelic drug studies often lack rigorous pharmaceutical development, proper blinding, and statistical design for participant numbers, leading to inefficiency and excessive costs. Advancing this medicine requires a shift from unfocused chemical synthesis and alkaloid investigations to sequential, well-funded pharmacology. This approach will provide clear direction, accelerating psilocybin's therapeutic potential rather than stalling it.
Abstract
The hundreds of psilocybin clinical trials initiated over the past twenty years comprising a myriad of potential indications may actually be slowing this potential game-changing mental health therapeutic agent's approval and is costing excessive amounts of capital. To fully evaluate the actual potential of psilocybin, purposeful clinical trials need to be designed well, executed efficiently, and analyzed utilizing sequential and statistically valid processes for each potential indication. This will require a change from the current exploratory forays to defined, well-funded, sequential pharmaceutical development practices, including adequate and appropriate blinding of studies, statistical design to determine the number of participants and more importantly, professional expertise in conducting multicenter trials. Unfortunately, these results demonstrate little real progress towards FDA approval of psilocybin and a field with no clear direction forward.