ISCTM autumn conference (International society for CNS clinical trials and methodology)
The international society for CNS clinical trials and methodology’s autumn conference brings in speakers from industry and academia and has a themed agenda around clinical trials for rare neurological disorders and those that enroll participants with suicidal ideation and behavior. Clario eCOA Science’s Brian Rundle will present a historical overview of insights in psychedelic research, with a view to learn from historical trends to inform study methodology for future clinical studies.
Poster session information:
Poster title: Insights in Psychedelic Research – Historical Overview
Date: Thursday, September 12, 2024
Time: 6:00 p.m. – 7:30 p.m. PT
Abstract:
Clinical Outcome Assessments (COAs) are extremely vital in clinical trials to understanding the efficacy and potency of psychedelic compounds on the persistence of pathological symptoms. As well, understanding historical data in this novel field is important for clinical trial design. This study aims to assess trends in COA endpoints over the last decade, with a focus on therapeutic area, psychedelic compound, and endpoints. ClinicalTrials.Gov was used to identify studies across a 20-year period (2004 to 2024). All psychedelic clinical trials from phase I to IV were considered for the research. Data were subsequently analyzed to assess COAs as primary and secondary trial endpoints. Additionally, drug treatment for key indications such as Depression disorders, PTSD, Anxiety disorders, and OCD-Related disorder were examined. COA data were based on available information from study descriptions. Not all studies provided sufficient endpoint detail in their study descriptions. Understanding the historical methodologies in psychedelic research is essential to preparing for future clinical trials, especially in context of safety, efficacy, and use of health technology. The overall low number of studies reporting any COAs in this area of interest is notable, and further exploration is needed to explain the particularly limited phase 3 volume. Consideration should be given to refining the methodologies in early phase studies to address the poor outcomes observed. Each psychedelic compound comes with unique considerations (e.g., differences in behavioral changes during dosing) and the COAs should assess these changes objectively. Additional guidance from the health authorities could help in understanding the requirements of psychedelic studies and inform new standards for collecting these complex data in clinical trials.
Authors:
- Brian Rundle – Scientific Advisor, eCOA Science & Consulting at Clario
- Reina Davis-Aoki – Scientific Advisor, eCOA Science & Consulting at Clario
- Prateek Verma – Director, eCOA Science & Consulting at Clario