β
Outcome MeasureOther

PGIC

Patient Global Impression of Change

2 Papers in Blossom

Clinical Thresholds

17
Very much improved
Score 1–1
Much improved
Score 2–2
Minimally improved
Score 3–3
No change
Score 4–4
Minimally worse
Score 5–5
Much worse
Score 6–6
Very much worse
Score 7–7

Outcome Data Across Studies

Reported results for PGIC across 2 studies with quantitative data.

Outcome data across 4 study arm–timepoint observations
SD
5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial
2025Exploratory
BPL-003 arm(experimental)2812———
5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial
2025Exploratory
BPL-003 arm(experimental)5612———
5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial
2025Exploratory
BPL-003 arm(experimental)8412———
A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in patients with treatment-resistant depression
2026Secondary
Biphasic(experimental)8510-1.6Δ——

Papers Using PGIC

Paywallindividual

A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in patients with treatment-resistant depression

In a 12‑week, open‑label phase 2a trial of a single 10 mg intranasal dose of 5‑methoxy‑N,N‑dimethyltryptamine (BPL‑003) in 12 patients with treatment‑resistant major depressive disorder, the drug was generally well tolerated with mostly mild–moderate adverse events and rapid discharge readiness (median ~98 minutes). A rapid and sustained mean MADRS reduction of 12–13 points was observed across Days 2–85, with most participants meeting response criteria and several achieving remission, supporting further evaluation in larger controlled trials.

Published
Journal
Journal of Psychopharmacology
Authors
Roberts, C., Seynaeve, M., Ermakova, A. O., Dunbar, F., Wells, H., Puri, A., Bird, C., Rucker, J. J.
Open Accessindividual

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial

In an open‑label Phase IIa trial (n-12), a single 10 mg intranasal dose of 5‑MeO‑DMT (BPL‑003) given alongside a 10‑week relapse‑prevention CBT programme was acceptable in safety and tolerability in people with moderate–severe alcohol use disorder. Over 12 weeks, participants showed large improvements in drinking (mean abstinent days rose from 33.2% to 80.8% and heavy drinking days fell from 56.2% to 13.2%), providing preliminary evidence of efficacy and supporting larger controlled trials.

Published
Journal
Addiction
Authors
Marsden, J., Kelleher, M., Dunbar, F., Ermakova, A. O., Mitcheson, L., Roberts, C., Rucker, J. J., Scott, G., Saeger, I., Small, F., Seynaeve, M.

Quick Facts

Full Name
Patient Global Impression of Change
Domain
Other
Papers Indexed
2
Score Range
1–7
Interpretation
Lower = better
Unit
points
All Measures