Psilocybin Treatment for PTSD Shows Positive Topline Results in Phase 2 Study


A single dose of Compass Pathways’ investigational COMP360 was well tolerated and showed durable improvements in CAPS-5 and SDS total scores compared to baseline.

A synthesized formulation of the psychedelic psilocybin (COMP360) has shown positive topline results in a phase 2 trial evaluating its safety and tolerability for the treatment of post-traumatic stress disorder (PTSD), Compass Pathways announced in a release.1

Psilocybin Treatment for PTSD Shows Positive Topline Results / Cannabis_Pic -

Psilocybin Treatment for PTSD Shows Positive Topline Results / Cannabis_Pic -

In the open-label, multi-center, phase 2 safety study (NCT05312151), psilocybin met its primary safety endpoint of proportion of patients with adverse events at 12 weeks, and its secondary efficacy endpoints of change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline and Sheehan Disability Scale (SDS) total score from baseline. The therapy was well tolerated and had a safety profile consistent with previous studies.

About COM201

Trial Name: The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder Identifier: NCT05312151

Sponsor: Compass Pathways

Summary: The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder.

“These results, with early and lasting improvement in symptoms following a single administration of COMP360, are highly encouraging,” Guy Goodwin, chief medical officer of Compass, said in a release.1 “These observations, even with a small, open-label study, suggest that COMP360 could provide a clinically meaningful benefit and substantially improve patient daily function and quality of life.”

READ MORE: Therapeutic Relationship Plays Key Role in Psychedelic Treatment

The study cohort included 22 adult patients with PTSD resulting from trauma in adulthood. During the trial, patients received a single 25 mg dose of psilocybin, as well as psychological support from a licensed professional. The support included preparing participants for the treatment session, observing and being present with patients during it, and supporting them after it was completed.

The study was conducted at The Institute of Psychiatry, Psychology and Neuroscience at King’s College London, the Icahn School of Medicine at Mount Sinai in New York, and Sunstone Therapies in Rockville, Maryland.

Results from the study showed that psilocybin was well tolerated, with no serious adverse events. The most common adverse events included headache, nausea, crying, and fatigue. Two patients experienced suicidal ideation that resolved during the study period. However, both of the patients had a previous history of suicidality. Following a single dose, there were durable improvements in both CAPS-5 and SDS total scores. Additionally, relative to baseline, response and remission rates were high, with early onset of symptom improvement.

“PTSD is commonly underdiagnosed and even when recognized it is often left untreated,” James Rucker, principal investigator on the study and lead for The Psychoactive Trials Group at King’s College London, said in a release.1 “There have been no new medicines approved for the treatment of PTSD in over 2 decades, and effective treatment options are limited. It’s promising to see positive signals from this study of investigational COMP360 psilocybin treatment in people with PTSD.”

The positive topline data follows initial 24-hour safety findings that were announced in December 2023.2 The study is believed to be the first that is reporting on psilocybin as a potential treatment for PTSD. Compass is also investigating psilocybin as a potential treatment for other psychiatric disorders, including treatment-resistant depression and anorexia nervosa.3

“The well tolerated safety profile for COMP360 in patients with PTSD, with no serious adverse events observed, advance our understanding of potential applications of COMP360,” Goodwin said.1 “We look forward to submitting the full results of this study for publication and potential presentation at an upcoming medical conference.”

READ MORE: Mental and Behavioral Health Resource Center

1. Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder. News Release. Compass Pathways. May 8, 2024. Accessed May 9, 2024.
2. Compass Pathways announces investigational COMP360 psilocybin treatment was well-tolerated in phase 2 study of post-traumatic stress disorder. News Release. Compass Pathways. December 19, 2023. Accessed May 9, 2024.
3. Pipeline. Compass Pathways. Accessed May 9, 2024.
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