Overview
- Researchers in Mannheim and Berlin tested a single 25 mg psilocybin dose plus psychotherapy against placebo in 144 adults with treatment‑resistant depression and saw symptom improvement without meeting the predefined six‑week primary endpoint of a 50% reduction.
- An expert cited a roughly three to five point change on the Hamilton Rating Scale for Depression as clinically meaningful, indicating benefits for some patients despite the shortfall on the main measure.
- Safety findings included one case of a persistent perceptual disturbance and reports of slightly increased suicidal thoughts on treatment days, underscoring the need for carefully supervised clinical settings.
- Commentators flagged methodological limits, noting participants discontinued existing antidepressants before dosing, which could have introduced withdrawal effects and muddied outcomes.
- Specialists view one‑ or two‑dose therapy paired with psychotherapy as promising but still experimental, calling for larger, longer studies, with U.S. approval bids expected in coming years and European access likely confined to trials or limited programs for now.