354
Participants
Start Date
April 30, 2014
Primary Completion Date
November 30, 2014
Study Completion Date
November 30, 2014
RBP-7000
RBP-7000 90 mg and 120 mg were a mixture of the ATRIGEL Delivery System and 90 mg and 120 mg risperidone, respectively. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. Subcutaneous RBP-7000 injections on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.
Placebo
Subcutaneous injection of placebo using the ATRIGEL Delivery System on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.
Risperidone
Oral risperidone 0.25 mg tablets daily for the first two days of the screening period. The two 0.25 mg tablets confirmed whether study participants had any negative reaction to risperidone prior to receiving a long-acting injection of risperidone (RBP-7000).
Neurobehavioral Research, Inc., Cedarhurst
CRI Lifetree, Philadelphia
New Hope Clinical Research, Charlotte
Florida Clinical Research Center, LLC, Orlando
Behavioral Clinical Research, Inc., North Miami
Innovative Clinical Research, Fort Lauderdale
Midwest Clinical Research Center, LLC, Dayton
Alexian Brothers Behavioral Health Hospital, Hoffman Estates
Uptown Research Institute, Chicago
St. Louis Clinical Trials, St Louis
PsychCare Consultants Research, St Louis
Via Christi Research, Wichita
Lake Charles Clinical Trials, LLC, Lake Charles
Woodland International Research Group, Inc., Little Rock
Woodland International Research Group, Inc., Springdale
Oklahoma Clinical Research Center, Oklahoma City
FutureSearch Clinical Trials, L.P., Dallas
Pillar Clinic Research, LLC, Dallas
FutureSearch Clinical Trials, L.P., Austin
Community Clinical Research, Inc., Austin
Altea Research Institute, Las Vegas
CNRI- Los Angeles, LLC, Pico Rivera
Comprehensive Clinical Development - Cerritos, CA, Cerritos
Collaborative Neuroscience Networks, Inc., Long Beach
Apostle Clinical Trials, Inc., Long Beach
Behavioral Research Specialists, LLC, Glendale
CNRI - San Diego, LLC, San Diego
Synergy Clinical Research of Escondido, Escondido
Excell Research, Inc., Oceanside
Pacific Research Partners, Oakland
J. Gary Booker, MD, APMC, Shreveport
CRI Lifetree, Marlton
Lead Sponsor
Indivior Inc.
INDUSTRY