SPL026 With or Without SSRIs in Participants With MDD

NCT05553691 | Completed Phase 1

• 2 other identifiers: CT026_0042022-001767-27
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; Depression; SSRI; N,N-dimethyltryptamine; DMT

Outcome Measures

Primary Outcomes (7)

• Safety & tolerability: Adverse Events

  Adverse events (AEs)

  Screening to End-of-Study Follow-up (Day 29)

• Safety & tolerability: Lab biochemistry

  Values of potential clinical importance

  Screening, Day -1 and Day 1

• Safety & tolerability: Vital signs - Heart Rate

  Heart rate

  Screening to Day 2

• Safety & tolerability: Vital signs - Blood pressure

  Blood pressure

  Screening to Day 2

• Safety & tolerability: Vital signs - Temperature

  Temperature

  Screening to Day 2

• Safety & tolerability: Electrocardiogram

  QTcX intervals

  Screening to Day 2

• Safety & tolerability: Suicidal Ideation

  Columbia-Suicide Severity Rating Scale

  Screening to End-of-Study Follow-up (Day 29)

Secondary Outcomes (5)

• Evaluation of plasma levels of DMT

  2, 5, 7, 10, 11, 13, 15, 30, 60, 120, 240 minutes post-dose

• Mystical Experience Questionnaire (MEQ)

  Day 1 (dosing day)

• Challenging Experience Questionnaire (CEQ)

  Day 1 (dosing day)

• Ruminative Responses Scale (RRS)

  Day -1 and Day 29

• Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  Day -1, Day 15 and Day 29

Other Outcomes (1)

• Exploratory efficacy: Montgomery-Åsberg Depression Rating Scale (MADRS)

  Day -1, Day 8, Day 15 and Day 29

Study Arms (2)

Test Cohort

EXPERIMENTAL

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

Control Cohort

EXPERIMENTAL

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

Interventions

SPL026 DRUG

Intravenous

Also known as: N,N-dimethyltryptamine, DMT

Control Cohort; Test Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Small Pharma Ltd: lead

Study Sites (2)

Mac Clinical Research

Manchester, Greater Manchester, M13 9NQ, United Kingdom

Location

MAC Clinical Research

Liverpool, Prescot, L34 1BH, United Kingdom

Location

Related Links

• Redacted Clinical Study Report Synopsis

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

N,N-Dimethyltryptamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fabian Devlin, MD

  MAC Clinical Research

  PRINCIPAL INVESTIGATOR

• Neel Bhatt, MD

  MAC Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 23, 2022
• Study Start: December 13, 2022
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)