A new clinical trial published in Nature Medicine found that one dose of DMT (SPL026) significantly reduced depression symptoms in two weeks — with effects lasting up to six months for some patients.

Helus' psychedelic derived from ayahuasca, a brew used in shamanistic rituals in South America, has shown promise as a treatment for depression.

A phase 2a randomized, placebo-controlled study shows –7.35 MADRS difference at 2 weeks with SPL026 compared with placebo. However, the study is not advancing.

Major depressive disorder (MDD) is a leading cause of disability worldwide, yet many patients have inadequate responses to current treatments. Dimethyltryptamine (DMT), a serotonergic psychedelic with rapid onset and short duration, shows promise as a potential antidepressant (AD), although clinical evidence in MDD remains limited. We conducted a phase IIa, double-blind, placebo-controlled, randomized clinical trial to evaluate the efficacy and safety of intravenous DMT (SPL026; DMT fumarate) in adults with moderate-to-severe MDD. Participants received a single 21.5-mg dose of DMT or placebo infused over 10 min, along with supportive psychotherapeutic support, followed by a 2-week assessment. A subsequent open-label phase offered all participants a second DMT dose. The primary outcome was the change in Montgomery–Åsberg Depression Rating Scale (MADRS) at 2 weeks. Secondary outcomes included response (≥50% reduction in MADRS score) and remission (MADRS ≤ 10). A total of 34 participants