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
You may not be if
Current diagnosis of certain personality disorders or persistent depressive disorder
Recent substance use disorders, excluding caffeine or nicotine
Active suicidal risk or recent suicidal attempt
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
Positive urine drug test for an illicit drug or cannabis
Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode
Recent initiation or change in psychotherapy
Clareo Health | ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
