Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Small Pharma Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | SPL026 With or Without SSRIs in Participants With MDD
