Speaker Bio
Dr. Karas is an associate director of global development at Mind Medicine and functioned at the clinical lead for the first randomized placebo controlled trial of LSD in modern history. Dr. Karas obtained her doctorate at Pacific University in Clinical Psychology and went on to specialize in geriatric neuropsychology. Dr. Karas previously worked on phase 2 and 3 clinical trials in neurodegenerative disorders before finding her way into psychedelic clinical trials. Dr. Karas is passionate about the return of psychedelics to psychiatry to treat patients who are lacking efficacious treatment options. Dr. Karas hopes that with thoughtful experimental designs in psychedelic clinical trials, all patients will have access to affordable treatment options globally.
ICPR 2024 Abstract
Potential unblinding of central raters in a large psychedelic clinical trial
Background: The use of central raters (CR) for the collection of key endpoints has become a prominent design feature in psychedelic clinical trials due to methodological issues surrounding functional unblinding (1) and has been adopted as part of recent FDA guidance (2). To date, little data exists from large psychedelic RCT’s examining if CRs remain blinded to treatment allocation.
Question/Hypothesis: Do CR’s in psychedelic clinical research trials remain blinded to treatment allocation? It is hypothesized that CR’s may experience functional unblinding while assessing key endpoints by spontaneous responses from subjects.
Methods: Data was collected during a phase 2b study of MM-120 (LSD) (3). For each study visit, upon completion of the primary endpoint (HAM-A), a CR who was blinded to all study information including the study visit, subject information, and treatment type, completed a ‘rater blinding questionnaire’ which consisted of a 5-point Likert Scale: 1. I am certain the subject received the active drug, 2. I believe the subject received the active drug, 3. I am unable to discern whether the subject received the active drug or placebo, 4. I believe the subject received placebo, 5. I am certain the subject received placebo.
Findings: The study collected 1500+ unique assessments of subjective CR blinding. Data supported CRs remaining blinded with >80% indicating they were unable to discern treatment group.
Conclusion: This is the first large psychedelic RCT to collect data on CR unblinding. Future analysis of unblinded study data should explore the relation between treatment allocation and CR scoring.