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NCT05870540 (BPL-003 in Treatment Resistant Depression): BVCT ex-ante prediction vs. reported outcome

On 24 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 1 Jul 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (superior to esketamine).

Clinical Trial

NCTID
NCT05870540
Drug Name
BPL-003
Drug MoA
intranasal 5-MeO-DMT
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Treatment Resistant Depression
Human Patients
196
Sponsor
atai Life Sciences
Phase
Phase 2

Prediction of , index 1692

Prospective Prediction
Prediction Index
1692
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient clinical benefit non-superior-non-inferior to GH001; moderately superior to esketamine + SNRI/SSRI; yet moderately inferior to CYB003)
Technical Prediction
SUCCESS (statistically significant clinical benefit in MADRS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
68 days in advance
Readout Data Interpretation
BPL003 (8mg) achieved statistically significant -12.1 points MADRS reduction at Day 29 (p = 0.0025); superior to esketamine that achieved placebo-adjusted -9 points MADRS reduction at Day 8 (see add'l link below); yet non-superior to –15.5 points MADRS reduction at Day 8 by GH001 (p<0.0001)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (superior to esketamine)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, With Open Label Extension, in Patients With Treatment-Resistant Depression
Phase
Phase 2
Status
Completed
Enrollment
196
Lead sponsor
Beckley Psytech Limited
Conditions
Treatment Resistant Depression
Interventions
DRUG: BPL-003; DRUG: BPL-003
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-09-14
Primary completion
2025-03-28
Completion
2025-07-03
Results first posted
2026-09-10
Primary outcomes
  • Core: Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Day 29 (12 mg vs 0.3 mg BPL-003) (4 weeks)
  • OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE (8 weeks)

NCT05870540 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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