Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

Part of paid clinical trials in Costa Mesa, California.

Sponsor
Forest Laboratories
Study ID
NCT00694707
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Placebo was supplied in capsules.
  • Cariprazine — DRUG
    Cariprazine was supplied in capsules
  • Risperidone — DRUG
    Risperidone was supplied in capsules

Study Details

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Key Dates

Start date
Jun 30, 2008
Status verified
May 2019
Primary completion
Aug 31, 2009
Completion
Aug 31, 2009

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants received placebo orally once a day for 6 weeks.
  • Experimental: Cariprazine 1.5 mg
    Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
  • Experimental: Cariprazine 3.0 mg
    Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
  • Experimental: Cariprazine 4.5 mg
    Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
  • Active Comparator: Risperidone 4.0 mg
    Participants received risperidone 4.0 mg orally once a day for 6 weeks.

Primary Outcome Measure

Change From Baseline to Week 6 in the PANSS Total Score [ Time Frame: Baseline to Week 6 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Forest Investigative SiteCosta MesaCalifornia92626-
Forest Investigative SiteLong BeachCalifornia90813-
Forest Investigative SiteOceansideCalifornia92056-
Forest Investigative SiteParamountCalifornia90723-
Forest Investigative SiteRiversideCalifornia92506-
Forest Investigative SiteWashington D.C.District of Columbia20016-
Forest Investigative SiteBradentonFlorida34208-
Forest Investigative SiteKissimmeeFlorida34741-
Forest Investigative SiteLake CharlesLouisiana70601-
Forest Investigative SiteBaltimoreMaryland21202-
Forest Investigative SiteFlowoodMississippi39232-
Forest Investigative SiteBridgetonMissouri63044-
Forest Investigative SiteCincinnatiOhio45219-
Forest Investigative SiteCharlestonSouth Carolina29405-
Forest Investigative SiteMemphisTennessee28117-
Forest Investigative SiteHoustonTexas77008-
Forest Investigative SiteHoustonTexas77021-
Forest Investigative SiteIrvingTexas75062-

Find similar trials in Costa Mesa, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Forest Investigative Site· Costa Mesa, CAForest Investigative Site· Long Beach, CAForest Investigative Site· Oceanside, CAForest Investigative Site· Paramount, CAForest Investigative Site· Riverside, CAForest Investigative Site· Washington D.C., DC

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