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

Phase 3

Terminated

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

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.

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

Arm && Interventions

Group	Intervention	Description
Placebo (Double-blind Treatment Period)	Placebo	Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Cariprazine 4.5 mg/day (Open-label Treatment Period)	Cariprazine	Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
Cariprazine 3.0 mg/day (Double-blind Treatment Period)	Cariprazine	Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Cariprazine 4.5 mg/day (Double-blind Treatment Period)	Cariprazine	Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Primary Outcome Measures

Name	Time	Method
Time to First Relapse During Double-blind Treatment Period	Randomization (Week 18) to End of Treatment (Week 44)	Time to Relapse is the number of days from randomization to first relapse. Relapse is defined as any 1 of the following: * Increase in Positive and Negative Syndrome Scale(PANSS) by ≥30% for participants who had total score of ≥50 at randomization or ≥10-point increased score with total score \<50 at randomization \[PANSS=30 questions where 1=absence of symptoms to 7=extremely severe symptom;total score=30 to 210;higher score more severe symptoms\] * Increase in Clinical Global Impression-Severity (CGI-S) score by 2 or more points \[1=normal to 7=among most extremely ill\] * Score of \>4 on 1 or more of 7 PANSS items:P1-delusions,P2-conceptual disorganization,P3-hallucinatory behavior,P6-suspiciousness,P7-hostility,G8-uncooperativeness,G14-poor impulse control * Deliberate self-injury * Initiation of treatment with mood stabilizer,antidepressant,antipsychotics or benzodiazepine that exceeds specified allowance * Psychiatric hospitalization * Exacerbation of psychiatric illness

Secondary Outcome Measures

Name	Time	Method

Locations (95): Pillar Clinical Research
🇺🇸
Richardson, Texas, United States
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
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Pillar Clinical Research
🇺🇸Richardson, Texas, United States