NASHVILLE, Tenn. (WZTV) — Could one dose of a psychedelic spray into your nose make a difference when several antidepressants haven’t? A new study offers an early clue, and researchers say there’s still more to learn.
A single dose of an experimental psychedelic nasal spray was linked to improved depression scores in adults whose depression had not improved after trying multiple antidepressants, according to a JAMA study published Oct. 26
The trial included 193 adults with moderate to severe depression. For this study, “treatment-resistant” meant their symptoms had not improved after two to five antidepressant trials during their current episode of depression. The researchers followed participants for eight weeks.
The drug, mebufotenin, is also known as 5-MeO-DMT. Researchers tested it as a nasal spray called mebufotenin benzoate. The word “benzoate” refers to the chemical form used in the spray.
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Participants were randomly assigned to receive one dose of the spray: 8 milligrams, 12 milligrams or a much smaller 0.3-milligram dose used as a comparison. That comparison group did receive the drug; it was not a no-treatment group.
Participants also received psychological support before, during and after dosing.
Researchers tracked symptoms using a rating scale, where higher scores mean more severe depression.
After 29 days, scores had fallen by an average of 11.1 points in the 12-milligram group, compared with 5.5 points in the low-dose group. About one-third of people in each full-dose group met the study’s definition of a response: a 50% or greater drop in their depression rating score. That compared with about 12% in the low-dose group.
The improvement in scores remained greater in the full-dose groups than in the low-dose group through the final follow-up at 57 days.
What participants experienced
The treatment was given in a clinic with medical staff nearby. Most participants were judged ready to leave within two hours, but the study protocol did not allow anyone to leave before four hours after dosing.
Side effects were reported in all three groups.
The most common included headache, nausea and pain where the spray was given. Nearly all reported side effects were considered mild or moderate.
One person who received the 12-milligram dose had two severe panic attacks that researchers considered related to the treatment.
What the study can, and can’t, tell us
This was a midstage trial, so it offers early evidence about how the treatment might work and what side effects it could cause. It does not establish whether the spray is safe and effective for wider use.
The study’s authors also noted that many participants and clinicians could guess who received a full dose because of the drug’s noticeable psychedelic effects.
Independent researchers who rated participants’ depression symptoms remained blinded to their dose, but the guessing could still affect how people experienced the study. Researchers also said the trial did not determine how much the psychological support contributed to the results.
The findings suggest the treatment deserves more study, but they do not establish it as a routine treatment for depression. Longer and larger trials would be needed to better understand its benefits, risks and how long any improvement may last.