A double-blind, randomized, placebo-controlled study of intravenous doses of SPL026 (DMT fumarate), a serotonergic psychedelic, in healthy subjects (Part A) and patients with major depressive disorder (Part B)

Small Pharma Ltd0 sites68 target enrollmentAugust 30, 2023

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Small Pharma Ltd
Enrollment: 68
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2023 Funder report results see attached file ISRCTN63465876_FunderReport_V1_20Jun23.pdf [1] (added 18/09/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38274414/ Part A results in healthy volunteers (added 30/01/2024)

Registry

who.int

Start Date

August 30, 2023

End Date

December 21, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Small Pharma Ltd

Eligibility Criteria

Inclusion Criteria

•1\. 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)
•2\. 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
•3\. Willing to be contacted by email and video call, and have online access; able to give fully informed written consent
•4\. Part A only: psychedelic\-naïve, ie have never taken a serotonergic psychedelic drug, in any form. Must be 25 years or older
•5\. Part B only: MDD diagnosis (as per DSM\-V); not on antidepressant medication or willing to discontinue antidepressant medication (e.g. selective serotonin reuptake inhibitor \[SSRI] treatment) for a sufficient time before and during the study
•6\. No psychedelic drug use in the 6 months before dosing

Exclusion Criteria

•1\. Pre\-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
•2\. Clinically relevant abnormal findings at the screening assessment
•3\. 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])
•4\. Positive tests for hepatitis B \& C, or HIV
•5\. Severe adverse reaction to any drug
•6\. Use of over\-the\-counter or prescribed medication (excluding oral contraceptives) within the previous 28 days (paracetamol \[acetaminophen] permitted up to 7 days, and antidepressant medication must have ceased for at least 14 days; 28 days for MOAIs) before the first dose of trial medication
•7\. Drug or alcohol abuse; use of cannabis in the 24 h before each study visit
•8\. Heavy smokers (\>10 \[Part A] or \> 20 cigarettes \[Part B] daily)
•9\. Supine blood pressure, heart rate, or QTcF outside the acceptable ranges
•10\. Participation in other clinical trials of unlicensed medicines, or loss of more than 400 ml blood, within the previous 3 months