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Policy

FDA Clears Large Psilocybin Trial for PTSD

FDA Clears Large Psilocybin Trial for PTSD

Psilocybin mushrooms

What they found

The FDA cleared a Phase 2b/3 trial of COMP360 psilocybin for PTSD; earlier data showed about a 30-point CAPS-5 drop after one 25 mg dose.

The FDA cleared a Phase 2b/3 trial of COMP360 psilocybin for PTSD; earlier data showed about a 30-point CAPS-5 drop after one 25 mg dose.

The number

~30-point average reduction in CAPS-5 scores

How solid is it?

n/a

n/a

Not a study

Not a study

Evidence ladder: Lab dish → Animal → Early human → Strong human. Reviews summarize earlier research.

At a glance

Latin name

Compound

COMP360 psilocybin

COMP360 psilocybin

Published in

Psychiatric News

Psychiatric News

Covered in Shroom Scan

Section

PSILOCYBIN & LEGISLATION

PSILOCYBIN & LEGISLATION

As it ran in Shroom Scan

PTSD Trial

PTSD Trial

The FDA cleared a Phase 2b/3 clinical trial testing COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). The 12-week study will give participants two sessions of 25 mg psilocybin (vs. 1 mg control) spaced about 4 weeks apart, measuring symptom change using the CAPS-5 PTSD severity scale at week 8, followed by a 40-week safety follow-up. Earlier Phase 2 data showed a ~30-point average reduction in CAPS-5 scores by week 4 after a single 25 mg dose, with no serious adverse events reported.

The FDA cleared a Phase 2b/3 clinical trial testing COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). The 12-week study will give participants two sessions of 25 mg psilocybin (vs. 1 mg control) spaced about 4 weeks apart, measuring symptom change using the CAPS-5 PTSD severity scale at week 8, followed by a 40-week safety follow-up. Earlier Phase 2 data showed a ~30-point average reduction in CAPS-5 scores by week 4 after a single 25 mg dose, with no serious adverse events reported.

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