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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
Conditions
Schizophrenia
Interventions
Drug: Placebo
Registration Number
NCT03593213
Lead Sponsor
AbbVie
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

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
587
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo (Double-blind Treatment Period)PlaceboCariprazine 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)CariprazineCariprazine 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)CariprazineCariprazine 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)CariprazineCariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Primary Outcome Measures
NameTimeMethod
Time to First Relapse During Double-blind Treatment PeriodRandomization (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
NameTimeMethod

Trial Locations

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

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