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

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
AbbVie
Study ID
NCT03593213
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    Cariprazine capsules, oral administration, once daily.
  • Placebo — DRUG
    Matching placebo capsules, oral administration, once daily.

Study Details

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 Dates

Start date
Jul 30, 2018
Status verified
Apr 2022
Primary completion
Feb 11, 2021
Completion
Feb 11, 2021

Study Design

Enrollment
587 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine 4.5 mg/day (Open-label Treatment Period)
    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.
  • Placebo Comparator: Placebo (Double-blind Treatment Period)
    Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
  • Experimental: Cariprazine 3.0 mg/day (Double-blind Treatment Period)
    Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
  • Experimental: Cariprazine 4.5 mg/day (Double-blind Treatment Period)
    Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Primary Outcome Measure

Time to First Relapse During Double-blind Treatment Period [ Time Frame: Randomization (Week 18) to End of Treatment (Week 44) ]

Locations (42)

FacilityCityStateZIPSite coordinators
Pillar Clinical ResearchBentonvilleArkansas72712-
Woodland International Research GroupLittle RockArkansas72211-
Woodland Research Northwest, LLCRogersArkansas72758-
Advanced Research Center, Inc.AnaheimCalifornia92805-
CITrials - BellflowerBellflowerCalifornia90706-
Synexus Clinical Research US, Inc.CerritosCalifornia90703-
ATP Clinical Research, Inc.Costa MesaCalifornia92626-
California Pharmaceutical Research Institute, Inc.Costa MesaCalifornia92626-
ProScience Research GroupCulver CityCalifornia90230-
Collaborative Neuroscience Research Network, LLC.Garden GroveCalifornia92845-
Behavioral Research Specialists, LLCGlendaleCalifornia91206-
Omega Clinical TrialsLa HabraCalifornia90631-
Synergy San DiegoLemon GroveCalifornia91945-
Alliance ResearchLong BeachCalifornia90807-
Excell Research, IncOceansideCalifornia92056-
Orange County Neuropsychiatric Research Center, LLCOrangeCalifornia92868-
CNRI-Los AngelesPico RiveraCalifornia90660-
University of California San DiegoSan DiegoCalifornia92103-8229-
Schuster Medical Research InstituteSherman OaksCalifornia91423-
Collaborative Neuroscience Research, LLCTorranceCalifornia90502-
Wilks & Safirstein MD PA D/B/A MD ClinicalHallandaleFlorida33009-
Southern Winds HospitalHialeahFlorida33012-
Research Centers of AmericaHollywoodFlorida33024-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Synexus Clinical Research, IncAtlantaGeorgia30328-
iResearch Atlanta LLCDecaturGeorgia30030-
Atlanta Behavioral Research, LLCDunwoodyGeorgia30338-
AMITA Health Alexian Brothers Center for Psychiatric ResearchHoffman EstatesIllinois60169-
Louisiana Clinical ResearchShreveportLouisiana71101-
CBH Health LLCGaithersburgMaryland20877-
Alea Research InstituteLas VegasNevada89102-
Altea ResearchLas VegasNevada85012-
Hassman Research InstituteBerlinNew Jersey08009-
Neurobehavioral Research, Inc.CedarhurstNew York11516-
New Hope Clinical ResearchCharlotteNorth Carolina28211-
Clinical Inquest Center Ltd.BeavercreekOhio45431-
OSY Psychiatry DepartmentColumbusOhio43210-
Professional Psychiatric ServicesMasonOhio45069-
Sooner Clinical ResearchOklahoma CityOklahoma23112-
Community Clinical Research, Inc.AustinTexas78754-
Pillar Clinical ResearchRichardsonTexas75042-
Pillar HealthcareRichardsonTexas75080-

Find similar trials in Bentonville, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Pillar Clinical Research· Bentonville, ARWoodland International Research Group· Little Rock, ARWoodland Research Northwest, LLC· Rogers, ARAdvanced Research Center, Inc.· Anaheim, CACITrials - Bellflower· Bellflower, CASynexus Clinical Research US, Inc.· Cerritos, CA

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