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An Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics & Exploratory Efficacy of Intravenous SPL026 Drug Product (DMT Fumarate) Alone or in Combination With SSRIs in Patients With Major Depressive Disorder

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Trial Profile

An Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics & Exploratory Efficacy of Intravenous SPL026 Drug Product (DMT Fumarate) Alone or in Combination With SSRIs in Patients With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 May 2024

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At a glance

  • Drugs N-N-dimethyltryptamine (Primary) ; Antidepressants; Serotonin uptake inhibitors
  • Indications Major depressive disorder
  • Focus Adverse reactions
  • Sponsors Small Pharma

    • Most Recent Events

    • 05 May 2024 Planned number of patients changed from 19 to 24.
    • 26 Sep 2023 According to a Small Pharma media release, company announced positive safety, tolerability and efficacy data from this study exploring the interaction between selective serotonin reuptake inhibitors and SPL026, native N, N dimethyltryptamine, in patients with Major Depressive Disorder.
    • 26 Sep 2023 Results of topline data from this study presented in a Small Pharma Media Release.

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