SPL026 With or Without SSRIs in Participants With MDD

Sponsor
Small Pharma Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05553691
Collaborator
(none)
24
2
2
3.6
12
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 SPL026Test 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics & Exploratory Efficacy of Intravenous SPL026 Drug Product (DMT Fumarate) Alone or in Combination With SSRIs in Patients With Major Depressive Disorder
Actual Study Start Date :
Dec 13, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: SPL026
Intravenous
Other Names:
  • N,N-dimethyltryptamine
  • DMT
  • Experimental: 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.

    Drug: SPL026
    Intravenous
    Other Names:
  • N,N-dimethyltryptamine
  • DMT
  • Outcome Measures

    Primary Outcome Measures

    1. Safety & tolerability: Adverse Events [Screening to End-of-Study Follow-up (Day 29)]

      Adverse events (AEs)

    2. Safety & tolerability: Lab biochemistry [Screening, Day -1 and Day 1]

      Values of potential clinical importance

    3. Safety & tolerability: Vital signs - Heart Rate [Screening to Day 2]

      Heart rate

    4. Safety & tolerability: Vital signs - Blood pressure [Screening to Day 2]

      Blood pressure

    5. Safety & tolerability: Vital signs - Temperature [Screening to Day 2]

      Temperature

    6. Safety & tolerability: Electrocardiogram [Screening to Day 2]

      QTcX intervals

    7. Safety & tolerability: Suicidal Ideation [Screening to End-of-Study Follow-up (Day 29)]

      Columbia-Suicide Severity Rating Scale

    Secondary Outcome Measures

    1. Evaluation of plasma levels of DMT [2, 5, 7, 10, 11, 13, 15, 30, 60, 120, 240 minutes post-dose]

      Pharmacokinetic parameter calculation in the Test Cohort compared to the Control Cohort

    2. Mystical Experience Questionnaire (MEQ) [Day 1 (dosing day)]

      MEQ in the Test Cohort compared to the Control Cohort

    3. Challenging Experience Questionnaire (CEQ) [Day 1 (dosing day)]

      CEQ in the Test Cohort compared to the Control Cohort

    4. Ruminative Responses Scale (RRS) [Day -1 and Day 29]

      RRS in the Test Cohort compared to the Control Cohort

    5. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [Day -1, Day 15 and Day 29]

      WEMWBS in the Test Cohort compared to the Control Cohort

    Other Outcome Measures

    1. Exploratory efficacy: Montgomery-Åsberg Depression Rating Scale (MADRS) [Day -1, Day 8, Day 15 and Day 29]

      MADRS in the Test Cohort compared to the Control Cohort

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mac Clinical Research Manchester Greater Manchester United Kingdom M13 9NQ
    2 MAC Clinical Research Liverpool Prescot United Kingdom L34 1BH

    Sponsors and Collaborators

    • Small Pharma Ltd

    Investigators

    • Principal Investigator: Fabian Devlin, MD, MAC Clinical Research
    • Principal Investigator: Neel Bhatt, MD, MAC Clinical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Small Pharma Ltd
    ClinicalTrials.gov Identifier:
    NCT05553691
    Other Study ID Numbers:
    • CT026_004
    • 2022-001767-27
    First Posted:
    Sep 23, 2022
    Last Update Posted:
    Jan 19, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Small Pharma Ltd
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 19, 2023