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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
354
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).
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.
Time frame: Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S)
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.
Time frame: Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation
Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 22 more locations
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.
Time frame: Day 1 to Week 8