Table 4.

Overview of clinical studies of Psilocybin for the treatment of PTSD.

Study First Author, Year	Sample Size	Method	Measures	Study Type	Effect	Statistical Outcome
PI: Adam Levin, M.D. Sponsor: Ohio State University (Not yet recruiting)	n = 15	Psilocybin to treat veterans with PTSD; open-label trial. Two doses (15 mg and 25 mg, respectively) of psilocybin, administered 2 weeks apart (PAP).	• C-SSRS • CAPS-5 • PCL-5	Phase II	Primary outcome: Type, severity, and frequency of adverse events, change in suicidal ideation and risk severity (measured by C-SSRS). Secondary outcome: Change in PTSD symptom profile and severity (measured by CAPS-5 and PCL-5)	N/A
PI: Matthew W Johnson, Ph.D. Sponsor: Johns Hopkins University (Not yet recruiting)	n = 30	Safety and tolerability of psilocybin in PTSD; open label. Intervention will consist of 3 psilocybin sessions with an interval of approximately 2 weeks between each session. A ‘3+3’ dose escalation trial design will be used to evaluate a range of possible dose sequences, with doses ranging from 15-45 mg. Safety, tolerability, and efficacy endpoints will be evaluated 2 weeks following each psilocybin session and at 1-month, 3-month, and 6-month follow-ups (PAP).	• C-SSRS • CAPS-5 • PCL-5	Phase I	Primary outcomes: Mean peak post-administration blood pressure & heart rate, mean pre-administration suicide ideation scores and mean change in suicide ideation scores (both measured by C-SSRS). Secondary outcome: Change in PTSD symptom profile and severity (measured by CAPS-5 and PCL-5)	N/A
PI: Rachel Yehuda, Ph.D. Sponsor: COMPASS Pathways (Currently active/ recruiting)	n = 20	The safety and tolerability of 25mg COMP360 psilocybin in participants with PTSD; open-label trial (PAP).	• C-SSRS • CAPS-5 • PCL-5	Phase II	Primary outcome: Safety (proportion of patients with adverse events) Secondary outcome: Change in PTSD symptom profile and severity (measured by CAPS-5, PCL-5, SDS) from baseline	N/A

Abbreviations: C-SSRS: Columbia Suicide Severity Rating Scale, CAPS-5: Clinician-Administered PTSD Scale for DSM-5, PCL-5: PTSD Checklist for DSM-5, PAP: Psychedelic-Assisted Psychotherapy, PTSD: Post-traumatic stress disorder, SDS: Sheehan Disability Scale.