Positive Data Shows Promise of 5-MeO-DMT in Patients When Used With SSRIs
Beckley Psytech has released encouraging results from its Phase 2a clinical trial of BPL-003, a synthetic formulation of 5-MeO-DMT. The psychedelic compound was administered to patients with treatment-resistant depression (TRD) who remained on a stable dose of selective serotonin reuptake inhibitors (SSRIs).
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Historically, most psychedelic studies have excluded patients taking SSRIs due to safety concerns and fears of reduced efficacy. This trial marks a significant departure, with results that may reshape how clinicians think about combining traditional antidepressants and psychedelic therapy.
Key Takeaways from the Study
| Category | Details |
|---|---|
| Compound | BPL-003 (intranasal 5-MeO-DMT) |
| Patient Population | Individuals with treatment-resistant depression on SSRIs |
| Safety Profile | No serious adverse events reported |
| Onset of Psychedelic Effects | ~15 minutes after dosing |
| Duration of Psychedelic Experience | Approximately 30 minutes |
| Efficacy Signal | Rapid and robust reduction in depressive symptoms |
| Trial Phase | Phase 2a |
| Dosing Protocol | Single dose of BPL-003 + psychotherapy |
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Fast Acting, Short Duration
One of the most striking features of BPL-003 is its pharmacokinetics. The psychedelic experience typically begins within 15 minutes and resolves within 30 minutes. This shorter time window may improve the practicality and scalability of psychedelic therapy in clinical settings, compared with compounds like psilocybin which can last several hours.
Despite the brief duration, the results were notable. Patients experienced a rapid and sustained reduction in depression scores, suggesting that even a short psychedelic experience can produce meaningful therapeutic outcomes when supported by structured therapy.
Safety and Co-Administration with SSRIs
A major concern in the field has been whether SSRIs would blunt the effects of psychedelics or increase the risk of adverse reactions. This study found no such interactions. There were no serious side effects, and patients tolerated the combination well. This outcome challenges the prevailing approach of requiring SSRI washout periods prior to psychedelic treatment.
Implications for Future Research
These results could have wide-ranging implications. By expanding the pool of eligible patients to include those who are already on SSRIs, psychedelic research and therapy may become more accessible. Beckley Psytech plans to continue development of BPL-003 with additional trials focused on efficacy, dosing, and long-term outcomes.
The findings offer new momentum for integrating psychedelic therapies into mainstream psychiatric care, especially for those who have exhausted conventional options.
