Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
- Registration Number
- NCT02109562
- Lead Sponsor
- Indivior Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. RBP-7000 90 mg RBP-7000 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 120 mg RBP-7000 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 90 mg Risperidone 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 120 mg Risperidone 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. Placebo Risperidone 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.
- Primary Outcome Measures
Name Time Method 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 Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation 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.
- Secondary Outcome Measures
Name Time Method Summary of Participants With Treatment-Emergent Adverse Events (TEAE) Day 1 to Week 8 An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.
A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.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 The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness.
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.
Trial Locations
- Locations (29)
Pillar Clinic Research, LLC
🇺🇸Dallas, Texas, 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
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
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
St. Louis Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
CRI Lifetree
🇺🇸Philadelphia, Pennsylvania, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Midwest Clinical Research Center, LLC
🇺🇸Dayton, Ohio, United States
Oklahoma Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
FutureSearch Clinical Trials, L.P.
🇺🇸Dallas, Texas, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
J. Gary Booker, MD, APMC
🇺🇸Shreveport, Louisiana, United States
Florida Clinical Research Center, LLC
🇺🇸Orlando, Florida, United States
Woodland International Research Group, Inc.
🇺🇸Springdale, Arkansas, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States