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About

Pre ICPR Events

About

Ellen James, PhD

Cybin

Speaker Bio

  • Doctorate in molecular biology, over 10 years of clinical and drug development experience.

  • Successfully progressed a variety of drugs through preclinical development and early phase clinical trials to proof-of-concept studies.

  • Experienced in psychedelic drug development from academic, regulatory, operational, therapy, commercial, IP, and scientific perspectives.

  • Most recent success includes completion of RCT proof-of-concept study of DMT-based drug product in MDD with significant primary endpoint.

ICPR 2024 Abstract

SPL026 (DMT fumarate) in combination with SSRIs for patients with Major Depressive Disorder

Selective serotonin reuptake inhibitors (SSRIs) are the dominant treatment for major depressive disorder (MDD). Recent studies with psychedelics have most often been with patients not currently taking SSRIs. SSRI withdrawal can be a disruptive experience. We previously completed a study which reported positive results with SPL026 (DMT fumarate) in patients with MDD (without SSRIs), with a mean difference between active and placebo at 2 weeks of -7.35 (Montgomery-Asberg Depression Rating scale (MADRS)) (p=0.023).

This open-label study investigated the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of a single SPL026 intravenous dose, alone or in combination with SSRIs. The test cohort (N=12) (“SSRI-Cohort”) consisted of patients currently on a stable, but not fully effective, treatment of SSRIs. The control (N=5) (“Non-SSRI-Cohort”) consisted of patients not currently using any pharmacological antidepressant treatment. Patients were recruited with a Hamilton Depression Rating Scale score of ≥14.

We observed no drug-related SAEs, 8 drug-related AEs in SSRI-Cohort, and 3 in Non-SSRI Cohort, all of which were mild-moderate, with the majority resolving during the dosing visit. Exploratory efficacy measures at 4 weeks found: mean MADRS change in SSRI-Cohort of -25.8 and -19.4 in Non-SSRI-Cohort; % response was 100% in SSRI-Cohort and 80% in Non-SSRI-Cohort; % remission was 92% in SSRI-Cohort and 20% in Non-SSRI-Cohort.

These results suggest that patients can safety continue their use of antidepressants while undergoing psychedelic treatment and that, in fact, it may be beneficial for patients to remain on their ongoing SSRIs. 

© 2007-2024 ICPR by OPEN Foundation, Amsterdam, the Netherlands
© 2007-2024 ICPR by OPEN Foundation, Amsterdam, the Netherlands
© 2007-2024 ICPR by OPEN Foundation, Amsterdam, the Netherlands