A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
AbbVie
Study ID
NCT03573297
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 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 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day

Key Dates

Start date
Jun 15, 2018
Status verified
Sep 2023
Primary completion
Sep 5, 2022
Completion
Sep 5, 2022

Study Design

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

Arms

  • Experimental: Double-Blind Cariprazine 3.0 mg/day
    Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.
  • Experimental: Double-Blind Cariprazine 1.5 mg/day
    Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
  • Placebo Comparator: Double-Blind Placebo
    Participants randomized to receive placebo QD for up to 39 weeks.
  • Experimental: Open Label Treatment
    Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.

Primary Outcome Measure

Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period [ Time Frame: From Week 16 to Week 55 ]

Locations (46)

FacilityCityStateZIPSite coordinators
Woodland International Research Group /ID# 232932Little RockArkansas72211-
Woodland Research Northwest, LLC /ID# 232982RogersArkansas72758-6442-
Advanced Research Center /ID# 233120AnaheimCalifornia92805-
California Pharmaceutical Research Institute Inc. /ID# 232745AnaheimCalifornia92804-
CI Trials /ID# 232642BellflowerCalifornia90706-7079-
Synexus Clinical Research US Inc. /ID# 232743CerritosCalifornia90703-
ATP Clinical Research, Inc /ID# 232979Costa MesaCalifornia92626-4607-
ProScience Research Group /ID# 232945Culver CityCalifornia90230-6632-
Collaborative Neuroscience Research - Orange County /ID# 233077Garden GroveCalifornia92845-
Behavioral Research Specialists, LLC /ID# 232980GlendaleCalifornia91206-4261-
Omega Clinical Trials LLC /ID# 233150La HabraCalifornia90631-3842-
Synergy San Diego /ID# 232740Lemon GroveCalifornia91945-2956-
Alliance for Research - Long Beach /ID# 232926Long BeachCalifornia90807-
NRC Research Institute /ID# 232741OrangeCalifornia92868-
CNRI-San Diego /ID# 232748San DiegoCalifornia92102-
Artemis Institute for Clinical Research /ID# 233151San MarcosCalifornia92078-2338-
Artemis Institute for Clinical Research /ID# 233152San MarcosCalifornia92078-2338-
Collaborative Neuroscience Research LLC /ID# 232750TorranceCalifornia90502-
Duplicate_MCB Clinical Research Centers LLC /ID# 232838Colorado SpringsColorado80910-
Velocity Clinical Research - Hallandale Beach /ID# 232647HallandaleFlorida33009-4427-
Research Centers of America - Hollywood FL /ID# 232649HollywoodFlorida33024-2706-
CNS Healthcare - Jacksonville /ID# 233160JacksonvilleFlorida32256-6039-
Meridien Research /ID# 232941MaitlandFlorida32751-
Miami Lakes Medical Research /ID# 232826Miami LakesFlorida33016-
University of South Florida /ID# 233093TampaFlorida33612-
Atlanta Center for Medical Research /ID# 232832AtlantaGeorgia30331-
Synexus Clinical Research, Inc /ID# 232950AtlantaGeorgia30328-
CenExcel iResearch LLC /ID# 233045DecaturGeorgia30030-
Atlanta Behavioral Research, LLC /ID# 232935DunwoodyGeorgia30338-
NeuroPsychiatric Research Practice & Associate LTD /ID# 232840WinfieldIllinois60190-
Louisiana Clinical Research /ID# 232685ShreveportLouisiana71101-
CBH Health LLC /ID# 232699GaithersburgMaryland20877-
St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709Saint CharlesMissouri63304-
Duplicate_Altea Research Institute /ID# 232784Las VegasNevada89102-
Hassman Research Institute /ID# 233088BerlinNew Jersey08009-
Neurobehavioral Research Inc /ID# 232791CedarhurstNew York11516-
New Hope Clinical Research Inc. /ID# 232716CharlotteNorth Carolina28211-
Richard Weisler MD, PA & Assoc /ID# 233049RaleighNorth Carolina27609-
Clinical Inquest Center Ltd /ID# 233043BeavercreekOhio45431-2573-
DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739ColumbusOhio43210-
Midwest Clinical Research Center /ID# 232737DaytonOhio45417-
Sooner Clinical Research /ID# 232931Oklahoma CityOklahoma73112-
Community Clinical Research Inc. /ID# 232672AustinTexas78754-
Pillar Clinical Research LLC /ID# 232667RichardsonTexas75080-
Pillar Clinical Research LLC /ID# 232673RichardsonTexas75080-
Family Psychiatry of The Woodlands /ID# 232943The WoodlandsTexas77381-

Find similar trials in Little Rock, AR

By condition
Bipolar disorderDepression
By specialty
PsychiatryMental healthBehavioral health
By research site
Woodland International Research Group· Little Rock, ARWoodland Research Northwest, LLC· Rogers, ARAdvanced Research Center· Anaheim, CACalifornia Pharmaceutical Research Institute Inc.· Anaheim, CACI Trials· Bellflower, CASynexus Clinical Research US Inc.· Cerritos, CA

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