Phase 2a trial of psychedelic shows promise for major depressive disorder
Written By : Medha Baranwal
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2023-02-02 14:30 GMT | Update On 2023-02-03 09:42 GMT
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UK: Patients who received at least one active dose of SPL026 with supportive therapy showed a durable improvement in depression symptoms, according to top-line results from a Phase IIa trial.
The trial showed that an intravenous N, N-Dimethyltryptamine (DMT), SPL026, with supportive therapy for major depressive disorder (MDD), met the primary endpoint. SPL026 demonstrated a statistically significant and clinically relevant reduction in depressive symptoms at two weeks post-dose than placebo. Further study of key secondary endpoints showed a long-lasting and rapid antidepressant effect to 12 weeks.
The trial investigated the safety and efficacy of intravenous SPL026 with supportive therapy among 34 patients with moderate/severe MDD. Dosing of patients was done with a short IV infusion of 21.5mg SPL026, leading to a 20 to the 30-minute psychedelic experience. People who entered the trial on pharmacological antidepressant medication were withdrawn from their treatment before dosing.
The two-staged Phase IIa study included a randomized, blinded, placebo-controlled phase. The primary endpoint was to examine the efficacy of an SPL026's single dose with supportive therapy (N=17) compared to a placebo with therapy (N=17) at two weeks post-dose. All study participants were subsequently enrolled on an open-label phase where they received an SPL026 single dose with supportive treatment and were followed for further 12 weeks in the study.
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