This treatment, already known as Spravato®, shows that it can quickly relieve resistant depression without associated antidepressant, a perspective that changes management for certain patients.
When antidepressants are no longer enough
Resistant depression concerns approximately a third of people with major depressive disorder, who do not respond to at least two antidepressants. These patients often find themselves in the face of heavy treatments, accumulating fatigue, weight gain, digestive disorders or drop in libido, side effects that sometimes grow to abandonment. Spravato®, approved in 2019, was so far reserved for use in combination with an oral antidepressant.
“”The magnitude and extent of the global depression epidemic is astounding. More than 280 million people worldwide live with a major depressive disorder (MDD), and the unsatisfied needs of these patients remain considerable“Said Adam Janik, medical director at Johnson & Johnson.
An unprecedented clinical trial and quick results
The study, carried out between 2020 and 2024 in 51 American centers, included 378 adults with resistant depression. Participants received either 56 mg, or 84 mg of nasal spray esketamine, or a placebo, twice a week for four weeks.
The results are clear: on the 28th day, the reduction in symptoms was significantly greater in patients treated with esketamine (−5.1 points for 56 mg and −6.8 for 84 mg on the MadRS scale, against placebo). And above all, improvement appeared at 24 hours after the first dose.
The number of patients to be treated to obtain a profit was estimated between 6.5 and 7, a score comparable or greater than combined treatments.
“”Spravato® in monotherapy offers a safe and effective treatment option for people living with treatment resistant to treatments, in particular for those who encounter tolerance problems limiting treatments or an absence of response with oral antidepressants“Explains Adam Janik.
A promising track, but still monitored
As in previous trials, certain side effects have been observed: nausea (24.8 %), sensations of dissociation (24.3 %), dizziness (21.7 %), headache (19 %). Most disappeared within hours of administration. No death or serious effect linked to the treatment has been reported.
“”The safety profile of Spravato® in autonomous processing was in accordance with existing clinical and real data when used with an oral antidepressant, and no new safety problem has been identified “insists Janik.
Despite these limits, the researchers recall that the exact mechanism of action of esketamine remains to be elucidated. “The data confirm what our team had supposed from the start. We followed science, and the results show that Spravato® is safe and effective, providing rapid and lasting relief to patients with resistant treatment,” concludes the researcher.