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Trial record 1 of 1 for:    NCT05553691
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SPL026 With or Without SSRIs in Participants With MDD

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ClinicalTrials.gov Identifier: NCT05553691
Recruitment Status : Completed
First Posted : September 23, 2022
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Small Pharma Ltd

Study Description
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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
Major Depressive Disorder Drug: SPL026 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 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 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 : December 13, 2022
Actual Primary Completion Date : August 3, 2023
Actual Study Completion Date : August 3, 2023

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Safety & tolerability: Adverse Events [ Time Frame: Screening to End-of-Study Follow-up (Day 29) ]
    Adverse events (AEs)

  2. Safety & tolerability: Lab biochemistry [ Time Frame: Screening, Day -1 and Day 1 ]
    Values of potential clinical importance

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

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

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

  6. Safety & tolerability: Electrocardiogram [ Time Frame: Screening to Day 2 ]
    QTcX intervals

  7. Safety & tolerability: Suicidal Ideation [ Time Frame: Screening to End-of-Study Follow-up (Day 29) ]
    Columbia-Suicide Severity Rating Scale


Secondary Outcome Measures :
  1. Evaluation of plasma levels of DMT [ Time Frame: 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) [ Time Frame: Day 1 (dosing day) ]
    MEQ in the Test Cohort compared to the Control Cohort

  3. Challenging Experience Questionnaire (CEQ) [ Time Frame: Day 1 (dosing day) ]
    CEQ in the Test Cohort compared to the Control Cohort

  4. Ruminative Responses Scale (RRS) [ Time Frame: Day -1 and Day 29 ]
    RRS in the Test Cohort compared to the Control Cohort

  5. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [ Time Frame: 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) [ Time Frame: Day -1, Day 8, Day 15 and Day 29 ]
    MADRS in the Test Cohort compared to the Control Cohort


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05553691


Locations
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United Kingdom
Mac Clinical Research
Manchester, Greater Manchester, United Kingdom, M13 9NQ
MAC Clinical Research
Liverpool, Prescot, United Kingdom, L34 1BH
Sponsors and Collaborators
Small Pharma Ltd
Investigators
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Principal Investigator: Fabian Devlin, MD MAC Clinical Research
Principal Investigator: Neel Bhatt, MD MAC Clinical Research
More Information
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Responsible Party: Small Pharma Ltd
ClinicalTrials.gov Identifier: NCT05553691    
Other Study ID Numbers: CT026_004
2022-001767-27 ( EudraCT Number )
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Small Pharma Ltd:
Major Depressive Disorder
MDD
Depression
 SSRI
N,N-dimethyltryptamine
DMT
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
N,N-Dimethyltryptamine
Hallucinogens
 Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists