Table 1 Full inclusion criteria

Consent

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

For sexually active persons of child-bearing potential, i.e. assigned female at birth: agree to use an effective or highly effective contraception for at least 1 month prior to screening and agreement to use such a method during trial, until the one-month follow-up is completed

For those assigned male at birth who are of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Ability to take oral medication and be willing to adhere to the study intervention regimen

Demographics

Any gender identity

Aged, 21–65 years

Clinical characteristics

Diagnosis of MDD as per the DSM-5 criteria for MDD (determined by clinical interview)

• Have a MADRS score between 18 and 35 at the time of screening