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NCT05800860 (GH001 in treatment-resistant depression): BVCT ex-ante prediction vs. reported outcome

On 5 Jun 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 3 Feb 2025 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
NCT05800860
Drug Name
GH001
Drug MoA
psychedelic 5-MeO-DMT
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
treatment-resistant depression
Human Patients
80
Sponsor
GH Research
Phase
Phase 2

Prediction of , index 1265

Prospective Prediction
Prediction Index
1265
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate clinical benefit)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
243 days in advance
Readout Data Interpretation
GH001 achieved statistically significant placebo-adjusted –15.5 points MADRS reduction at Day 8 (p<0.0001); superior to esketamine that achieved placebo-adjusted -9 points MADRS reduction at Day 8 (DOI-10.1001/jamapsychiatry.2017.3739)
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, Phase 2b Trial With an Open-label Extension to Determine the Safety and Efficacy of GH001 in Patients With Treatment-resistant Depression
Phase
Phase 2
Status
Completed
Enrollment
81
Lead sponsor
GH Research Ireland Limited
Conditions
Treatment-resistant Depression
Interventions
DRUG: GH001; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-05-24
Primary completion
2024-10-04
Completion
2025-03-11
Primary outcomes
  • Mean change in MADRS from Baseline to Day 7 (Baseline to Day 7)

NCT05800860 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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