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NCT05839509 (GH001 in Bipolar II Disorder): 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 10 Jan 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient (pending placebo data disclosure to evaluate efficacy competitiveness).

Clinical Trial

NCTID
NCT05839509
Drug Name
GH001
Drug MoA
psychedelic 5-MeO-DMT
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Bipolar II Disorder
Human Patients
6
Sponsor
GH Research
Phase
Phase 2

Prediction of , index 1263

Prospective Prediction
Prediction Index
1263
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
219 days in advance
Readout Data Interpretation
GH001 achieved statistically significant -16.8 points MADRS reduction at Day 8(p=0.0099; superior to -8 points MADRS reduction at Day 8 achieved by quetiapine; though absolute MADRS reduction values are not directly comparable due to varying placebo effects especially for psychiatric disorders
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient (pending placebo data disclosure to evaluate efficacy competitiveness)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode
Phase
Phase 2
Status
Terminated
Enrollment
6
Lead sponsor
GH Research Ireland Limited
Conditions
Bipolar II Disorder
Interventions
DRUG: GH001
Design
Single group · None
Primary purpose
Treatment
Start
2023-04-06
Primary completion
2024-11-13
Completion
2024-12-05
Primary outcomes
  • The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7 (From Baseline to Day 7)

NCT05839509 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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