SPL026 With or Without SSRIs in Participants With MDD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2023-08-03

Brief Summary

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The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine \[DMT\] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Test Cohort of patients already taking an SSRI for their depression, compared to the Control Cohort who are not already taking an SSRI. All patients will receive SPL026

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Cohort

Patients who are currently taking an SSRI that is not effective in fully relieving their depression (prescribed outside of study). Patients will be administered a single dose of SPL026 by intravenous infusion.

Group Type EXPERIMENTAL

SPL026

Intervention Type DRUG

Intravenous

Control Cohort

Patients who are not currently taking any pharmacological treatment for their depression. Patients will be administered a single dose of SPL026 by intravenous infusion.

Group Type EXPERIMENTAL

SPL026

Intervention Type DRUG

Intravenous

Interventions

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SPL026

Intravenous

Intervention Type DRUG

Other Intervention Names

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N,N-dimethyltryptamine DMT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No