A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Forest Laboratories
Study ID
NCT01412060
Phase
PHASE3
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 as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Study Details

The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

Key Dates

Start date
Sep 27, 2011
Status verified
Jun 2018
Primary completion
Sep 3, 2014
Completion
Sep 3, 2014

Study Design

Enrollment
765 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cariprazine - Open-label Phase
    Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
  • Experimental: Placebo - Double-blind Treatment Phase
    Participants received placebo orally once a day for 26 to 72 weeks.
  • Experimental: Cariprazine - Double-blind Treatment Phase
    Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks

Primary Outcome Measure

Time From Baseline to the First Symptom Relapse During the Double-blind Phase [ Time Frame: Up to 34 Weeks and Bi-Weekly thereafter until Week 92 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Forest Investigative Site 011Little RockArkansas72211-
Forest Investigative Site 018CerritosCalifornia90703-
Forest Investigative Site 007Costa MesaCalifornia92626-
Forest Investigative Site 026Culver CityCalifornia90230-
Forest Investigative Site 008Long BeachCalifornia90813-
Forest Investigative Site 002OceansideCalifornia92056-
Forest Investigative Site 019OrangeCalifornia92868-
Forest Investigative Site 001ParamountCalifornia90723-
Forest Investigative Site 020San DiegoCalifornia92123-
Forest Investigative Site 005Washington D.C.District of Columbia20016-
Forest Investigative Site 024LeesburgFlorida34748-
Forest Investigative Site 017AtlantaGeorgia30331-
Forest Investigative Site 021ChicagoIllinois60640-
Forest Investigative Site 023BaltimoreMaryland21202-
Forest Investigative Site 010RockvilleMaryland20850-
Forest Investigative Site 003FlowoodMississippi39232-
Forest Investigative Site 006Creve CoeurMissouri63141-
Forest Investigative Site 014St LouisMissouri63141-
Forest Investigative Site 012CedarhurstNew York11516-
Forest Investigative Site 022DaytonOhio45417-
Forest Investigative Site 015AustinTexas78731-
Forest Investigative Site 027AustinTexas78754-
Forest Investigative Site 025DallasTexas75231-
Forest Investigative Site 009HoustonTexas77021-
Forest Investigative Site 013HoustonTexas77008-

Find similar trials in Little Rock, AR

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Forest Investigative· Little Rock, ARForest Investigative· Cerritos, CAForest Investigative· Costa Mesa, CAForest Investigative· Culver City, CAForest Investigative· Long Beach, CAForest Investigative· Oceanside, CA

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