Research library / Clinical trial
A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in patients with treatment-resistant depression
Roberts C, Seynaeve M, Ermakova AO, et al. Journal of Psychopharmacology 2026;40(8):1247-1260
This small trial gave 12 people with hard-to-treat depression one intranasal dose of BPL-003, a nasal-spray form of the short-acting psychedelic 5-MeO-DMT, then followed them for 12 weeks. Most had some drug-related side effects, mainly nausea and nasal discomfort; one person had a severe but temporary rise in blood pressure. Most were judged ready to go home about an hour and a half after dosing, which matters for how practical clinic use would be. Depression scores dropped quickly and stayed around 12-13 points lower through to week 12, and most participants met response criteria at some point. Without a placebo group and with only 12 people, the study cannot separate the drug's effect from expectation or natural change. Larger controlled trials are needed.
What it found
- 9 of 12 participants had treatment-related adverse events (18 in total: 8 mild, 9 moderate, 1 severe rise in blood pressure that settled); nausea and nasal discomfort were most common
- Median time to being ready for discharge was 98 minutes after dosing
- MADRS depression scores fell by an average of 12.2-13.0 points at every timepoint from day 2 to day 85
- 10 of 11 assessed participants met response criteria and 7 reached remission at one or more timepoints