Clinical Research Directory

Inclusion Criteria: * Subjects meeting criteria for Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) currently in a Major Depressive Episode (MDE) as confirmed by the MINI International Neuropsychiatric Interview (MINI). * A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and at randomization, with no more than 20% improvement between these two visits. * Female subjects of childbearing potential must have a negative urine pregnancy test at enrolment (Visit 1) and be willing to use a reliable method of birth control (i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during the study. * Be able to understand and comply with the requirements of the study, as judged by the investigator(s). Exclusion Criteria: * Presence of a current or past history of psychotic symptoms or a diagnosis of schizophrenia or bipolar disorder. * History of non-response or intolerance to Cariprazine or other antipsychotic medications. * Concurrent use of other antipsychotic medications or medications known to interact with Cariprazine. --Significant medical conditions or unstable medical conditions that could interfere with participation in the study or pose a risk to the participant's safety. * Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the study.