SPL026 With or Without SSRIs in Participants With MDD

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Small Pharma Ltd
• Treatments: N,N-Dimethyltryptamine

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