The Objective of This Study is to Evaluate the 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
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Cariprazine; Placebo; Antidepressant Therapy (ADT)
Intervention description: Cariprazine supplied in capsules; Placebo supplied in capsules; ADT as prescribed by the physician per standard of care in clinical practice.
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 752.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD

Summary:

      The objective of this study is to evaluate the efficacy, safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
      who have had an inadequate response to antidepressants alone.
    

Eligibility criteria:

        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]).

          -  Participant must be an outpatient at the time of Visit 1 (Screening).

          -  Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5) criteria for MDD based on Structured Clinical Interview for DSM-5
             (SCID-5), with a current major depressive episode of at least 8 weeks and not
             exceeding 24 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.

          -  Participant demonstrates ability to follow study instructions and likely to complete
             all required visits.

          -  Participant must have an inadequate response, as measured by the modified
             antidepressant treatment response questionnaire (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 Participants must agree to continue
             taking the same ADT dosing regimen through completion of Visit 6/early termination
             (ET). Participants 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 Participants 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.

          -  Participant has a history of intolerance or hypersensitivity to cariprazine or other
             drugs of the same class or to rescue medications.