ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response

Prior treatment

• Positive urine drug test for an illicit drug or cannabis
• Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode

Other illness

• Current diagnosis of certain personality disorders or persistent depressive disorder
• Recent substance use disorders, excluding caffeine or nicotine
• History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features
• Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD
• History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)
• Allergy or sensitivity to ketamine or esketamine
• Significant cardiovascular disease
• Positive history of hepatitis B, hepatitis C, or HIV infection
• Unstable diabetes or uncontrolled medical conditions

Other

• Active suicidal risk or recent suicidal attempt
• Recent initiation or change in psychotherapy
  • Additional inclusion/exclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.

• Adults ≥18 and ≤65 years of age
• Provides written informed consent
• Clinical diagnosis of MDD
• History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode
• Currently treated with an approved antidepressant at a stable dose prior to Screening
• MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 at Screening and Baseline
• Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation