New findings on safety, tolerability and efficacy from a clinical study assessing the interaction of psychedelics and traditional pharma for the treatment of major depressive disorder (MDD) are out.
They correspond to U.K.’s short-acting psychedelic therapies developer Small Pharma’s (OTCQB: DMTTF) open-label Phase 1b study assessing the joint work of its “native” DMT compound, SPL026 and selective serotonin reuptake inhibitors (SSRIs.)
The trial studied the safety, tolerability, pharmacokinetics and pharmacodynamics (PK/PD) and exploratory efficacy of one 27.5 mg IV infusion of SPL026, both alone and in combination with SSRIs in 17 patients paired with support therapy, as follows:
The test cohort had 12 patients on a stable -and insufficient- SSRIs treatment course, while the control cohort had 5 patients not using any pharmacological treatment for their depression symptoms. Patients were recruited with moderate to severe MDD.
SPL026 was well-tolerated by all 17 patients, with no apparent differences between both cohorts ...