Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients

Last updated: October 22, 2018
Sponsor: Indivior Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Psychosis

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT02109562
RB-US-09-0010
  • Ages 18-55
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with placebo in the treatment of patients with schizophrenia.

This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses of RBP-7000 compared with placebo over an 8-week treatment period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females between the ages of 18 to 55 years, inclusive

  • Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4,text revision (DSM-IV-TR) criteria

  • Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, andRule (SAFER) interview

  • Subjects who are otherwise healthy on the basis of their physical examination

Exclusion

Exclusion Criteria:

  • Subjects who have an improvement in their total Positive and Negative Syndrome Scale (PANSS) score of 20% or greater between the initial screening visit and the first dayof treatment.

  • Subjects taking daily oral risperidone at a dose ≥ 6 mg/day

  • Subjects who have received a depot antipsychotic within 120 days of screen

  • Subjects with treatment resistant schizophrenia, as judged by the investigator, whohave been treated with antipsychotics for adequate durations and with adequatedosages.

Study Design

Total Participants: 354
Study Start date:
April 01, 2014
Estimated Completion Date:
November 30, 2014

Connect with a study center

  • Woodland International Research Group, Inc.

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Woodland International Research Group, Inc.

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • Comprehensive Clinical Development - Cerritos, CA

    Cerritos, California 90703
    United States

    Site Not Available

  • Synergy Clinical Research of Escondido

    Escondido, California 92025
    United States

    Site Not Available

  • Collaborative Neuroscience Networks, Inc.

    Garden Grove, California 92845
    United States

    Site Not Available

  • Behavioral Research Specialists, LLC

    Glendale, California 91206
    United States

    Site Not Available

  • Apostle Clinical Trials, Inc.

    Long Beach, California 90813
    United States

    Site Not Available

  • Collaborative Neuroscience Networks, Inc.

    Long Beach, California 90806
    United States

    Site Not Available

  • Pacific Research Partners

    Oakland, California 94612
    United States

    Site Not Available

  • Excell Research, Inc.

    Oceanside, California 92056
    United States

    Site Not Available

  • CNRI- Los Angeles, LLC

    Pico Rivera, California 90660
    United States

    Site Not Available

  • CNRI - San Diego, LLC

    San Diego, California 92012
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Innovative Clinical Research

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Innovative Clinical Research

    Ft. Lauderdale, Florida 33308
    United States

    Site Not Available

  • Behavioral Clinical Research, Inc.

    North Miami, Florida 33021
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC

    Orlando, Florida 32751
    United States

    Site Not Available

  • Uptown Research Institute

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Alexian Brothers Behavioral Health Hospital

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Via Christi Research

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana 70629
    United States

    Site Not Available

  • J. Gary Booker, MD, APMC

    Shreveport, Louisiana 71104-2136
    United States

    Site Not Available

  • PsychCare Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • St. Louis Clinical Trials

    Saint Louis, Missouri 63118
    United States

    Site Not Available

  • Midwest Research Group

    St Charles, Missouri 63304
    United States

    Site Not Available

  • PsychCare Consultants Research

    St Louis, Missouri 63128
    United States

    Site Not Available

  • Altea Research Institute

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • CRI Lifetree

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • CRI Lifetree

    Marltron, New Jersey 08053
    United States

    Site Not Available

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • New Hope Clinical Research

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Midwest Clinical Research Center, LLC

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Oklahoma Clinical Research Center

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • CRI Lifetree

    Philadelphia, Pennsylvania 19139
    United States

    Site Not Available

  • Community Clinical Research, Inc.

    Austin, Texas 78754
    United States

    Site Not Available

  • FutureSearch Clinical Trials, L.P.

    Austin, Texas 78734
    United States

    Site Not Available

  • FutureSearch Clinical Trials, L.P.

    Dallas, Texas 75231
    United States

    Site Not Available

  • Pillar Clinic Research, LLC

    Dallas, Texas 75243
    United States

    Site Not Available

  • Bayou Clinical Research, Ltd

    Houston, Texas 77007
    United States

    Site Not Available

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