Clinical TrialMajor Depressive Disorder (MDD)DMTPlaceboDMTPlaceboCompleted

SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

Randomised, double‑blind, placebo‑controlled Phase I/II two‑part study (n=66 actual) of IV SPL026 (DMT fumarate): single‑dose, dose‑escalation in healthy volunteers; patients with MDD receive dose 1 randomised vs placebo and an open‑label second dose 2 weeks later.

Target Enrollment
66 participants
Study Type
Phase I/II interventional
Design
Randomized, quadruple Blind

Detailed Description

Two‑part study: Part A tests single IV SPL026 in psychedelic‑naïve healthy volunteers in a parallel dose‑escalation design; Part B treats patients with moderate‑severe MDD with up to two single IV doses (dose 1 randomised double‑blind vs placebo; dose 2 open‑label active 2 weeks later).

Outcomes include safety and tolerability, pharmacokinetics and pharmacodynamics, and clinical efficacy measures (eg HAM‑D) with acute and follow‑up assessments.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

HV — SPL026

experimental

Healthy volunteers — single IV SPL026, dose-escalation, parallel-group.

Interventions

  • DMT
    via IV• single dose

    Single IV dose; dose-escalation in parallel groups (no mg specified).

HV — Placebo

inactive

Healthy volunteers — SPL026-matched placebo IV.

Interventions

  • Placebo
    via IV• single dose

    Placebo (SPL026-matched) single IV dose.

MDD — SPL026

experimental

Patients with MDD — up to two single IV doses; dose 1 randomised vs placebo, dose 2 open-label active.

Interventions

  • DMT
    via IV• single dose (up to 2 doses, 2 weeks apart)• 2 doses total

    Dose 1 randomised double-blind vs placebo; dose 2 open-label SPL026.

MDD — Placebo

inactive

Patients with MDD — placebo for dose 1 only.

Interventions

  • Placebo
    via IV• single dose

    Placebo given for dose 1; dose 2 is open-label active.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Normotensive male or female, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine, Mini-International Neuropsychiatric Interview (MINI) and Beck Scale for Suicidal Ideation (BSS); willing to follow the contraception requirements of the trial; willing to refrain from psychedelic drug use (excluding the study drug) during the trial and ≥ 3 months afterwards; willing to be contacted by email and video call, and have online access; able to give fully informed written consent. Part A only: psychedelic-naïve, i.e. have never taken a serotonergic psychedelic drug, in any form. Must be 25 years or older. Part B only: MDD diagnosis (as per DSM‑V); not on antidepressant medication or willing to discontinue antidepressant medication (eg selective serotonin reuptake inhibitor [SSRI] treatment) for a sufficient time before and during the study; no psychedelic drug use in the 6 months before dosing.

Exclusion Criteria

  • Exclusion Criteria:
  • Pre‑menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception; clinically relevant abnormal findings at the screening assessment; acute or chronic illness (other than MDD [Part B only]) or infection; clinically relevant abnormal medical history or concurrent medical condition (other than MDD [Part B only]); positive tests for hepatitis B & C, or HIV; severe adverse reaction to any drug; use of over‑the‑counter or prescribed medication (excluding oral contraceptives) within previous 28 days (paracetamol [acetaminophen] permitted up to 7 days, and antidepressant medication must have ceased for at least 14 days; 28 days for MAOIs) before first dose of trial medication; drug or alcohol abuse; use of cannabis in the 24 h before each study visit; heavy smokers (>10 [Part A] or >20 cigarettes [Part B] daily); supine blood pressure, heart rate, or QTcF outside the acceptable ranges; participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months; phobia of needles or blood; possibility that volunteer will not cooperate with the study.

Study Details

Locations

MAC Clinical Research — Liverpool, United Kingdom
Hammersmith Medicines Research — London, United Kingdom

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