The Object 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



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:2/9/2019
Start Date:November 10, 2018
End Date:July 9, 2021
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877-277-8566

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A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone

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


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
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Portland, Oregon 97210
Phone: 503-276-6224
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One Utah Avenue
Cherry Hill, New Jersey 08002
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2417 Marshall Ave.
Imperial, California 92251
760-355-0176
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 319-353-4434
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
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Anaheim, California 92804
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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3015 Flowers Road South
Atlanta, Georgia 30341
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Avon Lake, Ohio 44012
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Costa Mesa, California 92627
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Garden Grove, California 92845
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Glendale, California 91206
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Leawood, Kansas 66206
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Little Rock, Arkansas 72211
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Mason, Ohio 45040
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Mount Kisco, New York 10549
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Naperville, Illinois 60563
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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