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 and
local privacy requirements, where applicable (eg, Written Authorization for Use and
Release of Health and Research Study Information [US sites] and written Data
Protection 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 major
depressive episode of at least 8 weeks and not exceeding 18 months in duration at
Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.

- Diagnosis of MDD confirmed through a formal adjudication process (see Section 6.1)

- Patient demonstrates ability to follow study instructions and likely to complete all
required visits

- Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3
antidepressants administered during the current episode at an adequate dose (as per
package insert) and for at least 6 weeks duration, with at least one dose escalation
during 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 taking
the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking
more than one antidepressant at Screening, regardless of the indication, will need to
discontinue all other antidepressants prior to Visit 2 (Baseline).

- Male and female patients must agree to use a medically acceptable and highly effective
method of birth control during the course of the entire study

- Women of childbearing potential (only) must have a negative serum β-human chorionic
gonadotropin pregnancy test prior to Visit 2

Exclusion Criteria:

- Diagnosis of any current psychiatric diagnosis other than MDD (including those with
current intellectual development disability) with the exception of specific phobias

- Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs
of the same class or to rescue medications