Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Forest Laboratories
Study ID
NCT02670538
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    Cariprazine capsule one per day orally.
  • Placebo — DRUG
    Matching placebo capsule one per day orally.

Study Details

This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

Key Dates

Start date
Mar 31, 2016
Status verified
Feb 2019
Primary completion
Jan 18, 2018
Completion
Jan 18, 2018

Study Design

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

Arms

  • Experimental: Cariprazine 3.0 mg
    Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligrams (mg) capsule, one per day, orally for 2 weeks increased to cariprazine 3.0 mg capsule, one per day orally beginning on Day 15 for 4 weeks.
  • Experimental: Cariprazine 1.5 mg
    Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 6 weeks.
  • Placebo Comparator: Placebo
    Following a 7 to 14 days screening/washout period, matching placebo capsule, one per day, orally for 6 weeks.

Primary Outcome Measure

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (Week 0) to Week 6 ]

Locations (42)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Harmonex Neuroscience Research, Inc.DothanAlabama36303-
NoesisPharma, LLCPhoenixArizona85032-
Woodland International Research Group, LLCLittle RockArkansas72211-
Advanced Research Center, IncAnaheimCalifornia92805-
Radiant ResearchCerritosCalifornia90703-
Collaborative Neuroscience Network, LLCGarden GroveCalifornia92845-
Behavioral Research Specialists, LLCGlendaleCalifornia91206-
Excell Research, Inc.OceansideCalifornia92056-
Collaborative Neuroscience Network, LLCTorranceCalifornia90502-
Comprehensive Clinical ResearchWashington D.C.District of Columbia20016-
CNS Clinical Research GroupCoral SpringsFlorida33067-
MD ClinicalHallandaleFlorida33009-
Innovative Clinical Research, Inc.LauderhillFlorida33319-
Innova Clinical Trials, Inc.MiamiFlorida33133-
Research Centers of America, LLCOakland ParkFlorida33334-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Alexian Brothers Center for Psychiatric ResearchHoffman EstatesIllinois60169-
Capstone Clinical ResearchLibertyvilleIllinois60048-
Baber Research GroupNapervilleIllinois60563-
J. Gary Booker, MD, APMCShreveportLouisiana71104-
Coastal Research Associates, Inc.WeymouthMassachusetts02190-
Millennium Psychiatric AssociatesCreve CoeurMissouri63141-
St. Louis Clinical Trials, LLCSt LouisMissouri63141-
Center for Emotional FitnessCherry HillNew Jersey08002-
Pharmaceutical Research Associates, Inc.MarltonNew Jersey08053-
Brooklyn Medical InstituteBrooklynNew York11214-
SPRI Clinical Trials, LLCBrooklynNew York11235-
University at Buffalo Erie County Medical CenterBuffaloNew York14215-
Eastside Comprehensive Medical CenterNew YorkNew York10128-
Manhattan Behavioral MedicineNew YorkNew York10036-
Finger Lakes Clinical ResearchRochesterNew York14618-
Clinical Trials of America, IncHickoryNorth Carolina28601-
University of Cincinnati - Department of Psychiatry and Behavioral NeuroscienceCincinnatiOhio45219-
Professional Psychiatric ServicesMasonOhio45040-
Cutting Edge Research GroupOklahoma CityOklahoma73116-
Tulsa Clinical Research, LLCTulsaOklahoma74104-
Suburban Research AssociatesMediaPennsylvania19063-
Carolina Clinical Trials, Inc.CharlestonSouth Carolina29407-
Houston Endoscopy and Research CenterHoustonTexas77079-
Grayline Research CenterWichita FallsTexas76309-
Pacific Institute of Medical SciencesBothellWashington98011-

Find similar trials in Birmingham, AL

By condition
Bipolar disorderDepression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Alabama at Birmingham· Birmingham, ALHarmonex Neuroscience Research, Inc.· Dothan, ALNoesisPharma, LLC· Phoenix, AZWoodland International Research Group, LLC· Little Rock, ARAdvanced Research Center, Inc· Anaheim, CARadiant Research· Cerritos, CA

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