Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Inclusion Criteria:

• Written informed consent has been obtained.
• Written documentation has been obtained in accordance with the relevant country andlocal privacy requirements, where applicable (eg, Written Authorization for Use andRelease of Health and Research Study Information [US sites] and written DataProtection consent [EU sites]).
• Patient must be an outpatient at the time of Visit 1 (Screening).
• Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current majordepressive episode of at least 8 weeks and not exceeding 24 months in duration atVisit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
• Diagnosis of MDD confirmed through a formal adjudication process.
• Patient demonstrates ability to follow study instructions and likely to complete allrequired visits.
• Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3antidepressants administered during the current episode at an adequate dose (as perpackage insert) and for at least 6 weeks duration, with at least one dose escalationduring the current depressive episode.
• Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue takingthe same ADT dosing regimen through completion of Visit 6/ET. Patients who are takingmore than one antidepressant at Screening, regardless of the indication, will need todiscontinue all other antidepressants prior to Visit 2 (Baseline).
• Male and female patients must agree to use a medically acceptable and highly effectivemethod of birth control during the course of the entire study.
• Women of childbearing potential (only) must have a negative serum β-human chorionicgonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

• Diagnosis of any current psychiatric diagnosis other than MDD (including those withcurrent intellectual development disability) with the exception of specific phobias.
• Patient has a history of intolerance or hypersensitivity to cariprazine or other drugsof the same class or to rescue medications.