Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
- 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
- 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.
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
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
Scroll for more (85 remaining)Pillar Clinical Research🇺🇸Richardson, Texas, United States