Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
NCT ID: NCT02109562
Last Updated: 2018-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2014-04-30
2014-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RBP-7000 90 mg
Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 90 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
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.
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).
RBP-7000 120 mg
Risperidone tablets given during the screening period to check for sensitivity. RBP-7000 administered as a 120 mg subcutaneous injection on Days 1 and 29 for a total of two injections.
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.
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).
Placebo
Risperidone tablets given during the screening period to check for sensitivity. Placebo administered by subcutaneous injection on Days 1 and 29 for a total of two injections.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
No
Sponsors
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Indivior Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Developoment Manager
Role: STUDY_DIRECTOR
Indivior Inc.
Locations
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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
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States
CRI Lifetree
Philadelphia, Pennsylvania, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States
Community Clinical Research, Inc.
Austin, Texas, United States
FutureSearch Clinical Trials, L.P.
Dallas, Texas, United States
Pillar Clinic Research, LLC
Dallas, Texas, United States
Countries
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References
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Andrade C. Prazosin for Alcohol Use Disorder: Reply to Sinha. J Clin Psychiatry. 2021 Sep 21;82(6):21lr14076a. doi: 10.4088/JCP.21lr14076a. No abstract available.
Sinha R. Prazosin for Alcohol Use Disorder: A Clarification. J Clin Psychiatry. 2021 Sep 21;82(6):21lr14076. doi: 10.4088/JCP.21lr14076. No abstract available.
Le Moigne A, Csernansky J, Leadbetter RA, Andorn AC, Graham JA, Heath AT, Walling DP, Newcomer JW, Marder SR. PANSS Individual Item and Marder Dimension Analyses From a Pivotal Trial of RBP-7000 (Monthly Extended-Release Risperidone) in Schizophrenia Patients. J Clin Psychiatry. 2021 Sep 21;82(5):21m13906. doi: 10.4088/JCP.21m13906.
Other Identifiers
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RB-US-09-0010
Identifier Type: -
Identifier Source: org_study_id
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