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)
1 other identifier
interventional
354
1 country
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Apr 2014
Shorter than P25 for phase_3 schizophrenia
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
October 26, 2018
CompletedOctober 26, 2018
October 1, 2018
7 months
March 19, 2014
August 31, 2018
October 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in the Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms. Estimates (least square means and standard errors), 2-sided confidence intervals, and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.
Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
Secondary Outcomes (2)
Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S)
Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
Day 1 to Week 8
Study Arms (3)
RBP-7000 90 mg
EXPERIMENTALRisperidone 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 120 mg
EXPERIMENTALRisperidone 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.
Placebo
PLACEBO COMPARATORRisperidone 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.
Interventions
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.
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.
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).
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indivior Inc.lead
Study Sites (32)
Woodland International Research Group, Inc.
Little Rock, Arkansas, 72211, United States
Woodland International Research Group, Inc.
Springdale, Arkansas, 72764, United States
Comprehensive Clinical Development - Cerritos, CA
Cerritos, California, 90703, United States
Synergy Clinical Research of Escondido
Escondido, California, 92025, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Collaborative Neuroscience Networks, Inc.
Long Beach, California, 90806, United States
Apostle Clinical Trials, Inc.
Long Beach, California, 90813, United States
Pacific Research Partners
Oakland, California, 94612, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
CNRI- Los Angeles, LLC
Pico Rivera, California, 90660, United States
CNRI - San Diego, LLC
San Diego, California, 92012, United States
Innovative Clinical Research
Fort Lauderdale, Florida, 33308, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, 33021, United States
Florida Clinical Research Center, LLC
Orlando, Florida, 32751, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60169, United States
Via Christi Research
Wichita, Kansas, 67214, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, 70629, United States
J. Gary Booker, MD, APMC
Shreveport, Louisiana, 71104-2136, United States
St. Louis Clinical Trials
St Louis, Missouri, 63118, United States
PsychCare Consultants Research
St Louis, Missouri, 63128, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
CRI Lifetree
Marlton, New Jersey, 08053, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
New Hope Clinical Research
Charlotte, North Carolina, 28204, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112, United States
CRI Lifetree
Philadelphia, Pennsylvania, 19139, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78734, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
FutureSearch Clinical Trials, L.P.
Dallas, Texas, 75231, United States
Pillar Clinic Research, LLC
Dallas, Texas, 75243, United States
Related Publications (3)
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.
PMID: 34551220DERIVEDSinha 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.
PMID: 34551219DERIVEDLe 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.
PMID: 34551218DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Director, Clinical Development
- Organization
- Indivior, Inc.
Study Officials
- STUDY DIRECTOR
Global Clinical Developoment Manager
Indivior Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2014
First Posted
April 10, 2014
Study Start
April 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
October 26, 2018
Results First Posted
October 26, 2018
Record last verified: 2018-10