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

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02109562

Run by

Indivior Inc.

People needed

354

Starts

2014-04-01

Expected to finish

2014-11-01

Last updated by the study team

2018-10-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• CNRI - San Diego, LLC — San Diego, California, United States
• Innovative Clinical Research — Fort Lauderdale, Florida, United States
• Behavioral Clinical Research, Inc. — North Miami, Florida, United States
• Florida Clinical Research Center, LLC — Orlando, Florida, United States
• Uptown Research Institute — Chicago, Illinois, United States
• Alexian Brothers Behavioral Health Hospital — Hoffman Estates, Illinois, United States
• Via Christi Research — Wichita, Kansas, United States
• Lake Charles Clinical Trials, LLC — Lake Charles, Louisiana, United States
• J. Gary Booker, MD, APMC — Shreveport, Louisiana, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• PsychCare Consultants Research — St Louis, Missouri, United States
• Altea Research Institute — Las Vegas, Nevada, United States
• CRI Lifetree — Marlton, New Jersey, United States
• Neurobehavioral Research, Inc. — Cedarhurst, New York, United States
• New Hope Clinical Research — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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