Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Forest Laboratories
Study ID
NCT01104766
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine — DRUG
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
  • Aripiprazole — DRUG
    Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
  • Placebo — DRUG
    Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Study Details

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Key Dates

Start date
Apr 23, 2010
Status verified
Oct 2018
Primary completion
Dec 20, 2011
Completion
Dec 20, 2011

Study Design

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

Arms

  • Experimental: Cariprazine 3mg
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
  • Experimental: Cariprazine 6mg
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
  • Active Comparator: Aripiprazole 10mg
    Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
  • Placebo Comparator: Placebo
    Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Primary Outcome Measure

Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. [ Time Frame: Baseline to Week 6 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Woodland International Research Group, Inc.Little RockArkansas72211-
Woodland Research Northwest, LLCSpringdaleArkansas72764-
Synergy Clinical Research of EscondidoEscondidoCalifornia92025-
Excell Research, IncOceansideCalifornia92056-
Clinical Innovations, Inc.RiversideCalifornia92506-
Sharp Mesa Vista HospitalSan DiegoCalifornia92123-
Collaborative Neuroscience Network, Inc.TorranceCalifornia90502-
Colorado Clinical Trials, Inc.LittletonColorado80130-
Comprehensive Clinical Development, Inc.Washington D.C.District of Columbia20016-
Florida Clinical Research Center, LLCBradentonFlorida34208-
Hawaii Clinical Research CenterHonoluluHawaii96813-
Uptown Research Institute, LLCChicagoIllinois60640-
Alexian Brothers Center for Psychiatric ResearchHoffman EstatesIllinois60169-
Precise Research CentersFlowoodMississippi39232-
Millennium Psychiatric Associates, LLCCreve CoeurMissouri63141-
CRI Worldwide, LLCWillingboroNew Jersey08046-
Windsor-Laurelwood Center for Behavioral MedicineWilloughbyOhio44094-
Vanderbilt Psychiatric HospitalNashvilleTennessee37212-
Claghorn-Lesem Research Clinic, Ltd.HoustonTexas77008-
Pacific Institute of Medical SciencesBothellWashington98011-

Find similar trials in Little Rock, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Woodland International Research Group, Inc.· Little Rock, ARWoodland Research Northwest, LLC· Springdale, ARSynergy Clinical Research of Escondido· Escondido, CAExcell Research, Inc· Oceanside, CAClinical Innovations, Inc.· Riverside, CASharp Mesa Vista Hospital· San Diego, CA

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