BioinvestGPT

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NCT05066672 (SPN820 in treatment-resistant depression): BVCT ex-ante prediction vs. reported outcome

On 19 Jan 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 18 Feb 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05066672
Drug Name
SPN820 (NV-5138)
Drug MoA
mTORC1 activator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
treatment-resistant depression
Human Patients
400
Sponsor
Supernus Pharmaceuticals
Phase
Phase 2

Prediction of , index 1877

Prospective Prediction
Prediction Index
1877
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in MADRS inferior to lumateperone)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in MADRS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
30 days in advance
Readout Data Interpretation
SPN820 failed to achieve statistical significance in MADRS total score
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
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 Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NV-5138 in Adults With Treatment Resistant Depression
Phase
Phase 2
Status
Completed
Enrollment
250
Lead sponsor
Navitor Pharmaceuticals, Inc.
Conditions
Treatment Resistant Depression
Interventions
DRUG: NV-5138; DRUG: matched placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-01-18
Primary completion
2025-01-21
Completion
2025-01-21
Results first posted
2026-04-17
Primary outcomes
  • Change From Baseline to Week 4 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. (Baseline to Week 4)

NCT05066672 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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