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NCT05624268 (COMP360 in treatment-resistant depression): BVCT ex-ante prediction vs. reported outcome

On 11 Feb 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 23 Jun 2025 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
NCT05624268
Drug Name
COMP360
Drug MoA
5HT2AR agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
treatment-resistant depression (TRD)
Human Patients
255
Sponsor
Compass Pathways
Phase
Phase 3

Prediction of , index 1438

Prospective Prediction
Prediction Index
1438
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to SoC and to 5-MeO-DMT)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
132 days in advance
Readout Data Interpretation
COMP360 achieved statistically significant -3.6 points MADRS reduction at Week 6( p <0.001); inferior to esketamine that achieved placebo-adjusted -9 points 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, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression
Phase
Phase 3
Status
Completed
Enrollment
258
Lead sponsor
COMPASS Pathways
Conditions
Treatment Resistant Depression
Interventions
DRUG: Psilocybin
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-01-24
Primary completion
2025-05-28
Completion
2026-04-15
Primary outcomes
  • COMP360 25 mg versus placebo for the change from baseline in MADRS total score (Week 6)

NCT05624268 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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