10 for 10: Every Patient in a Small Postpartum Depression Trial of Inhaled 5-MeO-DMT Went Into Remission
A Phase 2a trial of GH Research's GH001 — inhaled, synthetic 5-MeO-DMT (mebufotenin) — published in The Journal of Clinical Psychiatry (Vol. 87, Issue 3), reported that all 10 women enrolled with peripartum-onset major depressive disorder achieved remission by day 8, first observed just two hours after their final dose. Average MADRS score fell from 36.7 at baseline to a 35.4-point reduction by day 8 (P < .0001). No serious adverse events were reported; headache was the most common side effect, and the company reported no treatment-emergent suicidal ideation.
The design matters as much as the result: open-label, single-arm, 10 patients, no control group — exactly the kind of early signal that looks dramatic and needs a much larger, placebo-controlled trial to hold up. GH Research hasn't announced a postpartum-specific Phase 3; its confirmed pivotal program is for treatment-resistant depression, where GH001 already posted stronger-powered Phase 2b data. Worth noting: Reunion Neuroscience is running a separate, better-funded postpartum depression program (luvesilocin) on a different compound entirely — two companies chasing the same indication with unrelated molecules, tracked side by side on our trials page.