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NCT05203341 (NBI-1065845 in Major Depressive Disorder): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 23 Apr 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: overall statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05203341
Acronym
SAVITRI
Drug Name
NBI-1065845
Drug MoA
AMPAR PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Major Depressive Disorder
Human Patients
183
Sponsor
Neurocrine Biosciences
Phase
Phase 2

Prediction of , index 1362

Prospective Prediction
Prediction Index
1362
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
145 days in advance
Readout Data Interpretation
significant MADRS for one dose (likely low dose) yet insignificant for another dose (likely high dose); anti-correlation between dosage and efficacy.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
overall statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)
Phase
Phase 2
Status
Completed
Enrollment
183
Lead sponsor
Neurocrine Biosciences
Conditions
Major Depressive Disorder
Interventions
DRUG: Placebo; DRUG: NBI-1065845
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-02-21
Primary completion
2024-01-10
Completion
2024-02-21
Primary outcomes
  • Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28 (Baseline, Day 28)

NCT05203341 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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