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SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

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ClinicalTrials.gov Identifier: NCT04673383
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Small Pharma Ltd

Tracking Information
First Submitted Date  ICMJE December 10, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date March 19, 2021
Actual Study Start Date  ICMJE February 4, 2021
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
  • Safety and tolerability in healthy volunteers [ Time Frame: Up to three months after a single dose ]
    Safety and tolerability measured by lab biochemistry, adverse events and intensity rating scale to measure tolerability of the psychedelic experience
  • Efficacy of SPL026 in MDD patients with moderate to severe depression [ Time Frame: 2 weeks after a single dose ]
    Montgomery-Åsberg Depression Rating Scale (MADRS) score (where 7 - 19 is mild depression, 20 - 34 is moderate depression, and >34 is severe depression) change from baseline at 2 weeks after the first dose (± 2 days)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients
Official Title  ICMJE A Double-blind, Randomised, 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)
Brief Summary SPL026 (N,N-dimethyltryptamine [DMT] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (MDD).
Detailed Description

2-part study. Part A in psychedelic-naïve healthy volunteers. Part B in patients with MDD who score moderate-severe on Ham-D.

Healthy volunteers will receive a single dose of SPL026 in a dose-escalation parallel group study.

Patients will receive up to 2 single doses of SPL026, 2 weeks apart. Dose 1 will be randomised double-blind with placebo. Dose 2 will be open label, active SPL026.

SPL026 will be administered by IV injection. Safety and tolerability, PK, PD and efficacy will be measured.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
RCT
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: SPL026
    Intravenous solution
    Other Names:
    • DMT
    • dimethyltryptamine
    • n,n-dimethytryptaimine
  • Drug: Placebo
    SPL026-matched placebo
    Other Names:
    • Dummy
    • SPL026-matched placebo
Study Arms  ICMJE
  • Experimental: Healthy volunteers (active)
    SPL026 to be administered by IV injection
    Intervention: Drug: SPL026
  • Experimental: Healthy volunteers (placebo)
    SPL026-matched placebo to be administered by IV injection
    Intervention: Drug: Placebo
  • Experimental: Patients (active)
    SPL026 to be administered by IV injection
    Intervention: Drug: SPL026
  • Experimental: Patients (placebo)
    SPL026-matched placebo to be administered by IV injection
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2020)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception; clinically relevant abnormal findings at the screening assessment; 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]); positive tests for hepatitis B & C, or HIV; severe adverse reaction to any drug; use of over-the-counter or prescribed medication (excluding oral contraceptives) within 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 first dose of trial medication; drug or alcohol abuse; use of cannabis in the 24 h before each study visit; heavy smokers (> 10 [Part A] or > 20 cigarettes [Part B] daily); supine blood pressure, heart rate, or QTcF outside the acceptable ranges; participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months; phobia of needles or blood; possibility that volunteer will not cooperate with the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Recruitment Manager 08007838792 recruit@hmrlondon.com
Contact: Ellen James, PhD 07734821583 ellen.james@smallpharma.co.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04673383
Other Study ID Numbers  ICMJE CT026_001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan for this yet.
Responsible Party Small Pharma Ltd
Study Sponsor  ICMJE Small Pharma Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jan Steiner, MD Oxford Therapeutics Consulting
Principal Investigator: David Erritzoe, MD Imperial College London
Principal Investigator: Malcolm Boyce, MD Hammersmith Medicines Research
PRS Account Small Pharma Ltd
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP