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NCT05711940 (COMP360 in Treatment Resistant Depression): BVCT ex-ante prediction vs. reported outcome

On 22 Jan 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Feb 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05711940
Drug Name
COMP360 (psilocybin)
Drug MoA
5-HT2A receptor agonist (psychedelic)
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Treatment Resistant Depression
Human Patients
572
Sponsor
COMPASS Pathways / ATAI Life Sciences
Phase
Phase 3

Prediction of , index 1439

Prospective Prediction
Prediction Index
1439
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to SoC and to 5MeO-DMT)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
757 days in advance
Readout Data Interpretation
COMP360 achieved -3.8 point MADRS difference (25mg vs 1mg) at week 6 (p<0.001), inferior to esketamine that achieved placebo-adjusted -9 point MADRS reduction at Day 8 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression
Phase
Phase 3
Status
Active not recruiting
Enrollment
572
Lead sponsor
COMPASS Pathways
Conditions
Treatment Resistant Depression
Interventions
DRUG: Psilocybin
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-02-14
Primary completion
2025-11-13
Completion
2026-12
Primary outcomes
  • COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score. (Week 6)

NCT05711940 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials