SPL026 With or Without SSRIs in Participants With MDD

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05553691
• Other study ID #: CT026_004
• Secondary ID: 2022-001767-27
• Status: Completed
• Phase: Phase 1
• Start date: December 13, 2022
• Est. completion date: August 3, 2023

Study information

• Verified date: June 2024
• Source: Small Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SPL026
Intravenous

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Liverpool	Prescot
United Kingdom	Mac Clinical Research	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Small Pharma Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory efficacy: Montgomery-Åsberg Depression Rating Scale (MADRS)	MADRS in the Test Cohort compared to the Control Cohort	Day -1, Day 8, Day 15 and Day 29
Primary	Safety & tolerability: Adverse Events	Adverse events (AEs)	Screening to End-of-Study Follow-up (Day 29)
Primary	Safety & tolerability: Lab biochemistry	Values of potential clinical importance	Screening, Day -1 and Day 1
Primary	Safety & tolerability: Vital signs - Heart Rate	Heart rate	Screening to Day 2
Primary	Safety & tolerability: Vital signs - Blood pressure	Blood pressure	Screening to Day 2
Primary	Safety & tolerability: Vital signs - Temperature	Temperature	Screening to Day 2
Primary	Safety & tolerability: Electrocardiogram	QTcX intervals	Screening to Day 2
Primary	Safety & tolerability: Suicidal Ideation	Columbia-Suicide Severity Rating Scale	Screening to End-of-Study Follow-up (Day 29)
Secondary	Evaluation of plasma levels of DMT	Pharmacokinetic parameter calculation in the Test Cohort compared to the Control Cohort	2, 5, 7, 10, 11, 13, 15, 30, 60, 120, 240 minutes post-dose
Secondary	Mystical Experience Questionnaire (MEQ)	MEQ in the Test Cohort compared to the Control Cohort	Day 1 (dosing day)
Secondary	Challenging Experience Questionnaire (CEQ)	CEQ in the Test Cohort compared to the Control Cohort	Day 1 (dosing day)
Secondary	Ruminative Responses Scale (RRS)	RRS in the Test Cohort compared to the Control Cohort	Day -1 and Day 29
Secondary	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)	WEMWBS in the Test Cohort compared to the Control Cohort	Day -1, Day 15 and Day 29

External Links

•   Redacted Clinical Study Report Synopsis