Clinical TrialMajor Depressive Disorder (MDD)DMTDMTCompleted

SPL026 With or Without SSRIs in Participants With MDD

Open-label Phase I interventional study (n=24 planned; registry reports 18 actual) testing single IV doses of SPL026 (DMT fumarate) in MDD patients on SSRIs versus those not on SSRIs to assess safety and tolerability.

Target Enrollment
18 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This Phase I, non-randomised, parallel-cohort study compares patients on a stable SSRI (Test Cohort) with patients not on antidepressants (Control Cohort); all participants receive a single intravenous infusion of SPL026 (DMT fumarate) to assess safety and tolerability.

Primary outcomes focus on safety and tolerability via vitals, ECG, labs and adverse events; eligibility excludes recent psychedelic use, MAOI antidepressants, significant medical/psychiatric comorbidity, and significant suicide risk.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Test Cohort

experimental

Patients currently taking a single SSRI at a stable dose for at least 6 weeks; receive single IV dose of SPL026.

Interventions

  • DMT
    via IV• single dose• 1 doses total

    Intravenous infusion of SPL026 (DMT fumarate); dose not reported in registry fragment.

Control Cohort

experimental

Patients not currently taking antidepressant medication for at least 6 months; receive single IV dose of SPL026.

Interventions

  • DMT
    via IV• single dose• 1 doses total

    Intravenous infusion of SPL026 (DMT fumarate); dose not reported in registry fragment.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • MDD diagnosis
  • Previously tried at least one approved method of treatment for their depression
  • No monoamine oxidase-inhibitor class antidepressants for at least 3 months
  • Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine
  • No psychedelic drug use in the 6 months before dosing until the end of the study
  • Willing to follow the contraception requirements of the trial
  • Willing to be contacted by email and video call, and have online access
  • Able to give fully informed written consent
  • Test Cohort only: currently on a stable dose of an unspecified single SSRI alone and not in combination with any other psychiatric medications, for at least 6 weeks prior to Screening with no intention of making any changes
  • Control Cohort only: no antidepressant medication for 6 months before dosing

Exclusion Criteria

  • Substance use disorder
  • Current or clinically relevant history of a psychotic disorder, or first-degree relatives with a clinically relevant history of a psychotic disorder
  • Significant history of mania
  • Significant risk of suicide
  • Clinically relevant abnormal findings at the screening assessment
  • Blood pressure, heart rate, or QTcF outside the acceptable ranges
  • Acute or chronic illness (other than MDD) or infection
  • Clinically relevant abnormal medical history or concurrent medical condition (other than MDD)
  • Use of any serotonergic psychedelics within 6 months prior to dosing
  • Patients of child-bearing potential who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
  • History of a severe adverse reaction to any drug or sensitivity to serotonergic psychedelic drugs
  • Use of over-the-counter or prescribed medication (excluding oral contraceptives, hormone replacement therapy and SSRIs [Test Cohort only]) within previous 28 day before dose of trial medication; or paracetamol or ibuprofen within 4 hours prior to dosing

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment18 participants
  • Timeline
    Start: 2022-10-01
    End: 2023-02-01
  • Compounds
    DMTDMT
  • Topic
    Major Depressive Disorder (MDD)

Locations

Mac Clinical Research — Manchester, Greater Manchester, United Kingdom
MAC Clinical Research — Liverpool, Prescot, United Kingdom

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