• Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode).

• Participant's current major depressive episode must be confirmed by independent assessment.

• The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.

• Have a MADRS total score of 25 or higher at Screening and Baseline.

• A change in MADRS total score between Screening and Baseline of ≤20%.