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
Intervention description: Cariprazine supplied in capsules; Placebo supplied in capsules
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 759.0
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]).

          -  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 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.

          -  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.