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NCT06360419 (Solriamfetol in major depressive disorder): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 1 Apr 2025 readout could not be adjudicated and sits outside the scored cohort.

Clinical Trial

NCTID
NCT06360419
Acronym
PARADIGM
Drug Name
Solriamfetol
Drug MoA
norepinephrine-dopamine reuptake inhibitor and TAAR1 agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
major depressive disorder (MDD)
Human Patients
346
Sponsor
Axsome Therapeutics
Phase
Phase 3

Prediction of , index 1901

Prospective Prediction
Prediction Index
1901
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in MADRS non-inferior-non-superior-to lumateperone + SoC)
Technical Prediction
SUCCESS (statistically significant clinical benefit in MADRS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
46 days in advance
Readout Data Interpretation
solriamfetol failed to meet the primary endpoint MADRS
Press Release
Prediction Result
Prediction Accuracy
Unadjudicatable Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient; unadjudicatable prediction because the official MoA of solriamfetol as a TAAR1 agonist is likely to be misinformation that shall be adjudicated with the readouts of both ENGAGE study and the SUSTAIN study against our updated ex-ante predictions No. 1900 and No. 1902 in which solriamfetol was modelled without TAAR1 agonism
Prediction Classification
—

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
Phase
Phase 3
Status
Completed
Enrollment
346
Lead sponsor
Axsome Therapeutics, Inc.
Conditions
Major Depressive Disorder
Interventions
DRUG: Solriamfetol 300 mg; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2024-03-18
Primary completion
2024-12-31
Completion
2025-03-26
Primary outcomes
  • Montgomery-Åsberg Depression Rating Scale (MADRS) (6 weeks)
  • Incidence of treatment-emergent adverse events (6 weeks)

NCT06360419 on ClinicalTrials.gov

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