Safety and Efficacy of Cariprazine in Schizophrenia

Part of paid clinical trials in Costa Mesa, California.

Sponsor
Forest Laboratories
Study ID
NCT01104779
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.
  • 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 27, 2010
Status verified
Oct 2018
Primary completion
Dec 15, 2011
Completion
Dec 15, 2011

Study Design

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

Arms

  • Experimental: Cariprazine (3-6 mg/day)
    Cariprazine once daily fixed-flexible low dose
  • Experimental: Cariprazine (6-9 mg/day)
    Cariprazine once daily fixed-flexible high dose
  • Placebo Comparator: Placebo
    Placebo

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 (15)

FacilityCityStateZIPSite coordinators
Forest Investigative Site 48Costa MesaCalifornia92626-
Forest Investigative Site 50Long BeachCalifornia90813-
Forest Investigative Site 42ParamountCalifornia90723-
Forest Investigative Site 054San DiegoCalifornia92102-
Forest Investigative Site 41KissimmeeFlorida34741-
Forest Investigative Site 055AtlantaGeorgia30308-
Forest Investigative Site 44RockvilleMaryland20850-
Forest Investigative Site 45St LouisMissouri63118-
Forest Investigative Site 52Las VegasNevada89102-
Forest Investigative Site 40CedarhurstNew York11516-
Forest Investigative Site 46CincinnatiOhio45219-
Forest Investigative Site 47PhiladelphiaPennsylvania19139-
Forest Investigative 49MemphisTennessee38119-
Forest Investigative Site 51HoustonTexas77021-
Forest Investigative Site 43IrvingTexas75062-

Find similar trials in Costa Mesa, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Forest Investigative· Costa Mesa, CAForest Investigative· Long Beach, CAForest Investigative· Paramount, CAForest Investigative· San Diego, CAForest Investigative· Kissimmee, FLForest Investigative· Atlanta, GA

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