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

  • End date
    Jul 9, 2021
  • participants needed
  • sponsor
Updated on 29 November 2020
Clinical Trials Registry Team
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Pharmasite Research, Inc. (4.3 mi away) Contact
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adjunctive treatment
depressive episode
major depressive disorder
antidepressant therapy


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

Treatment Placebo, cariprazine
Clinical Study IdentifierNCT03738215
Last Modified on29 November 2020

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Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Endogenous depression or Major depression?
Do you have any of these conditions: Major depression or major depressive disorder or major depressive disorders or Endogenous depression?
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 -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
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