Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 64
Updated:3/15/2019
Start Date:July 30, 2018
End Date:June 7, 2021
Contact:Clinical Trials Registry Team
Email:IR‐CTRegistration@Allergan.com
Phone:877‐277‐8566

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A Double-Blind, Placebo-Controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 mg/d compared
with placebo in prevention of relapse in patients with schizophrenia

2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared
with placebo in prevention of relapse in patients with schizophrenia who were initially
stabilized on a target dose of 4.5 mg/d


Inclusion Criteria:

- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.

- Ability to follow study instructions, complete study assessment tools with minimal
assistance and no alteration to the assessment tools, and likely to complete all
required visits.

- Patient meets DSM-5 criteria for schizophrenia as determined by SCID-5.

- PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.

- Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive
symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behavior;
P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

- Currently meeting DSM-5 criteria for any of the following:

- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

- Bipolar I and II disorder

- Autism spectrum disorder, intellectual development disorder, delirium, major/minor
neurocognitive disorder

- History of meeting DSM-5 criteria for substance-related disorders (excluding
caffeine-related and tobacco-related disorders) within the prior 3 months before Visit
1.

- Prior participation in any clinical trials involving experimental or investigational
drugs within 6 months before Visit 1 or planned during the study.

- Female patients who are pregnant, planning to become pregnant during the course of the
study, or are currently lactating.
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Culver City, California 90230
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Atlanta, Georgia 30328
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Austin, Texas 78754
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Beavercreek, Ohio 45432
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17800 Woodruff Avenue
Bellflower, California 90706
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Cedarhurst, New York 11516
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Charlotte, North Carolina 28204
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DeSoto, Texas 75115
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Dunwoody, Georgia 30338
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263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
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Gaithersburg, Maryland 20877
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Garden Grove, California 92845
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Hoffman Estates, Illinois 60169
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Hollywood, Florida 33024
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2300 Maitland Center Parkway
Orlando, Florida 32810
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Pico Rivera, California 90660
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Richardson, Texas 75080
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609 West Dyke Road
Rogers, Arkansas 72758
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