SPL026 With or Without SSRIs in Participants With... — Clinical Trial Details

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.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Excluded

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

Company

Product

Legal

SPL026 With or Without SSRIs in Participants With MDD

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Test Cohort

Interventions

Control Cohort

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators