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NCT04985942 (Lumateperone in Major Depressive Disorder): BVCT ex-ante prediction vs. reported outcome

On 9 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 Apr 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04985942
Drug Name
Lumateperone
Drug MoA
D1R/D2R/D4R/5TH2AR antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Major Depressive Disorder
Human Patients
485
Sponsor
Intra-Cellular Therapies
Phase
Phase 3

Prediction of , index 352

Prospective Prediction
Prediction Index
352
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
98 days in advance
Readout Data Interpretation
-4.9 placebo-adjusted delta in MADRS score (p<0.0001) & CGI-S (p<0.0001).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Phase
Phase 3
Status
Completed
Enrollment
485
Lead sponsor
Intra-Cellular Therapies, Inc.
Conditions
Major Depressive Disorder
Interventions
DRUG: Lumateperone; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2021-07-30
Primary completion
2024-02-22
Completion
2024-02-27
Results first posted
2025-05-02
Primary outcomes
  • Montgomery-Åsberg Depression Rating Scale (Day 43)

NCT04985942 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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