Mirror PR to Forgejo / mirror (pull_request) Waiting to run

Details

vida: extract claims from 2025-06-23-compass-pathways-comp005-psilocybin-phase3-trd

- Source: inbox/queue/2025-06-23-compass-pathways-comp005-psilocybin-phase3-trd.md
- Domain: health
- Claims: 2, Entities: 2
- Enrichments: 2
- Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5)

Pentagon-Agent: Vida <PIPELINE>

2026-05-10 04:33:02 +00:00

2.1 KiB

Raw Blame History

COMP005 Phase 3 Trial

Sponsor: Compass Pathways
Intervention: COMP360 psilocybin 25mg single dose
Indication: Treatment-resistant depression
Status: Completed, positive primary endpoint
Reported: June 23, 2025

Trial Design

Phase: 3
Design: Randomized, double-blind, placebo-controlled
Sample Size: n=258
Sites: 32 sites in the United States
Population: Treatment-resistant depression (≥2 failed antidepressant courses)
Intervention: Single dose COMP360 25mg vs. placebo
Protocol: Embedded psychological support (preparation, monitored session, integration)

Primary Endpoint

MADRS change from baseline at Week 6:

Treatment difference: -3.6 points (95% CI [-5.7, -1.5])
p<0.001 (highly statistically significant)

Secondary Outcomes

Response Rate: 25% achieved clinically meaningful MADRS reduction (≥25%) at week 6
Durability: Improvement maintained through 26-week follow-up after single dose
Rapid Onset: Statistically significant benefit from next day after dosing

Safety Profile

All treatment-emergent adverse events: mild or moderate severity
Most adverse events resolved within 24 hours
Frequently reported: headache, nausea, anxiety, visual hallucination
No clinically meaningful imbalance in suicidal ideation between arms
No unexpected safety findings

Historical Significance

First investigational psychedelic to report positive Phase 3 efficacy data
First classic psychedelic to reach Phase 3 evidence level
Establishes proof-of-concept for FDA approval pathway for psychedelic therapeutics

Clinical Context

Effect size (-3.6 MADRS points) comparable to existing TRD augmentation strategies (2-4 points)
Single-dose 26-week durability represents paradigm shift from daily-dosing chronic treatment model
Psychological support protocol is mandatory component, not optional adjunct
Treatment-resistant depression population: ~7M Americans who have failed 2+ antidepressant courses

Timeline

2025-06-23 — Primary endpoint results announced: MADRS -3.6 (p<0.001), first positive Phase 3 data for any psychedelic

2.1 KiB Raw Blame History