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Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP-7000 as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)

NCT02109562•Indivior Inc.

View on ClinicalTrials.gov

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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, and Rule (SAFER) interview
•Subjects who are otherwise healthy on the basis of their physical examination

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 day of 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, who have been treated with antipsychotics for adequate durations and with adequate dosages.

Locations (32)

Woodland International Research Group, Inc.

Little Rock, Arkansas, United States

Woodland International Research Group, Inc.

Springdale, Arkansas, United States

Comprehensive Clinical Development - Cerritos, CA

Cerritos, California, United States

Synergy Clinical Research of Escondido

Escondido, California, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Collaborative Neuroscience Networks, Inc.

Long Beach, California, United States

Apostle Clinical Trials, Inc.

Long Beach, California, United States

Pacific Research Partners

Oakland, California, United States

Excell Research, Inc.

Oceanside, California, United States

CNRI- Los Angeles, LLC

Pico Rivera, California, United States

Key Dates

Start Date

April 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

November 1, 2014

Last Updated

October 26, 2018

Enrollment

354

ACTUAL participants

Conditions

Schizophrenia

Interventions

RBP-7000

DRUG

Placebo

DRUG

Risperidone

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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