Safety, blood levels and effects of N,N-dimethyltryptamine [DMT (SPL026)] in healthy participants and participants with major depressive disorder

Phase 2

Completed

• Conditions: Major depressive disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN63465876
• Lead Sponsor: Small Pharma Ltd

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-21
• Study Start: 2023-08-30
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

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
11. Phobia of needles or blood
12. Possibility that the volunteer will not cooperate with the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified