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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (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

Key facts

Study ID

NCT03593213

Run by

AbbVie

People needed

587

Starts

2018-07-30

Expected to finish

2021-02-11

Last updated by the study team

2022-04-11

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
• 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.
• Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
• Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
• Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

You may not qualify if…

• 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 Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.

Where it is running

• Woodland International Research Group — Little Rock, Arkansas, United States
• Woodland Research Northwest, LLC — Rogers, Arkansas, United States
• Advanced Research Center, Inc. — Anaheim, California, United States
• CITrials - Bellflower — Bellflower, California, United States
• Synexus Clinical Research US, Inc. — Cerritos, California, United States
• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• California Pharmaceutical Research Institute, Inc. — Costa Mesa, California, United States
• ProScience Research Group — Culver City, California, United States
• Collaborative Neuroscience Research Network, LLC. — Garden Grove, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Omega Clinical Trials — La Habra, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Alliance Research — Long Beach, California, United States
• Excell Research, Inc — Oceanside, California, United States
• Orange County Neuropsychiatric Research Center, LLC — Orange, California, United States
• CNRI-Los Angeles — Pico Rivera, California, United States
• University of California San Diego — San Diego, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Collaborative Neuroscience Research, LLC — Torrance, California, United States
• Wilks & Safirstein MD PA D/B/A MD Clinical — Hallandale, Florida, United States
• Southern Winds Hospital — Hialeah, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• Synexus Clinical Research, Inc — Atlanta, Georgia, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Pillar Clinical Research — Bentonville, Arkansas, United States

Full record on ClinicalTrials.gov

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