Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients

• Sponsor: Indivior Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02109562
• Collaborator: (none)
• Enrollment: 354
• Locations: 32
• Arms: 3
• Duration (Months): 7
• Patients Per Site: 11.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: RBP-7000; Drug: Placebo; Drug: Risperidone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 354 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.; Other Names: risperidone in Atrigel ; Drug: 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 Names: Risperdal
Experimental: 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.	Drug: 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.; Other Names: risperidone in Atrigel ; Drug: 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 Names: Risperdal
Placebo Comparator: 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.	Drug: 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.; Drug: 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 Names: Risperdal

Outcome Measures

Primary Outcome Measures

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 [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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woodland International Research Group, Inc.	Little Rock	Arkansas	United States	72211
2	Woodland International Research Group, Inc.	Springdale	Arkansas	United States	72764
3	Comprehensive Clinical Development - Cerritos, CA	Cerritos	California	United States	90703
4	Synergy Clinical Research of Escondido	Escondido	California	United States	92025
5	Behavioral Research Specialists, LLC	Glendale	California	United States	91206
6	Collaborative Neuroscience Networks, Inc.	Long Beach	California	United States	90806
7	Apostle Clinical Trials, Inc.	Long Beach	California	United States	90813
8	Pacific Research Partners	Oakland	California	United States	94612
9	Excell Research, Inc.	Oceanside	California	United States	92056
10	CNRI- Los Angeles, LLC	Pico Rivera	California	United States	90660
11	CNRI - San Diego, LLC	San Diego	California	United States	92012
12	Innovative Clinical Research	Fort Lauderdale	Florida	United States	33308
13	Behavioral Clinical Research, Inc.	North Miami	Florida	United States	33021
14	Florida Clinical Research Center, LLC	Orlando	Florida	United States	32751
15	Uptown Research Institute	Chicago	Illinois	United States	60640
16	Alexian Brothers Behavioral Health Hospital	Hoffman Estates	Illinois	United States	60169
17	Via Christi Research	Wichita	Kansas	United States	67214
18	Lake Charles Clinical Trials, LLC	Lake Charles	Louisiana	United States	70629
19	J. Gary Booker, MD, APMC	Shreveport	Louisiana	United States	71104-2136
20	St. Louis Clinical Trials	Saint Louis	Missouri	United States	63118
21	PsychCare Consultants Research	Saint Louis	Missouri	United States	63128
22	Altea Research Institute	Las Vegas	Nevada	United States	89102
23	CRI Lifetree	Marlton	New Jersey	United States	08053
24	Neurobehavioral Research, Inc.	Cedarhurst	New York	United States	11516
25	New Hope Clinical Research	Charlotte	North Carolina	United States	28204
26	Midwest Clinical Research Center, LLC	Dayton	Ohio	United States	45417
27	Oklahoma Clinical Research Center	Oklahoma City	Oklahoma	United States	73112
28	CRI Lifetree	Philadelphia	Pennsylvania	United States	19139
29	FutureSearch Clinical Trials, L.P.	Austin	Texas	United States	78734
30	Community Clinical Research, Inc.	Austin	Texas	United States	78754
31	FutureSearch Clinical Trials, L.P.	Dallas	Texas	United States	75231
32	Pillar Clinic Research, LLC	Dallas	Texas	United States	75243

Sponsors and Collaborators

• Indivior Inc.

Investigators

• Study Director: Global Clinical Developoment Manager, Indivior Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indivior Inc.
• ClinicalTrials.gov Identifier: NCT02109562
• Other Study ID Numbers: RB-US-09-0010
• First Posted: Apr 10, 2014
• Last Update Posted: Oct 26, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Indivior Inc.: Schizophrenia; Schizophrenic; Schizophrenias; Risperidone
• Additional relevant MeSH terms: Schizophrenia; Risperidone

Study Results

Participant Flow

Pre-assignment Detail	A total of 538 subjects were screened for study participation at 33 sites in the US, including 354 subjects randomly assigned to treatment. Four subjects were found to be randomized incorrectly; therefore, they were withdrawn from the study and did not receive study drug (counted as 'Physician Decision' for reason d/c below).

Arm/Group Title	RBP-7000 90 mg	RBP-7000 120 mg	Placebo
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	116	119	119
Safety	115	117	118
Intent to Treat (ITT)	111	114	112
COMPLETED	90	85	84
NOT COMPLETED	26	34	35

Baseline Characteristics

Arm/Group Title	RBP-7000 90 mg	RBP-7000 120 mg	Placebo	Total
Arm/Group Description	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.	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.	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.	Total of all reporting groups
Overall Participants	115	117	118	350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.5 (9.41)	40.6 (9.45)	42.4 (9.07)	41.1 (9.33)
Age, Customized (Count of Participants)
20 years and under	1 0.9%	2 1.7%	1 0.8%	4 1.1%
21 to 30 years	16 13.9%	20 17.1%	16 13.6%	52 14.9%
31 to 40 years	38 33%	32 27.4%	28 23.7%	98 28%
41 to 50 years	41 35.7%	43 36.8%	49 41.5%	133 38%
51 to 55 years	19 16.5%	20 17.1%	24 20.3%	63 18%
Sex: Female, Male (Count of Participants)
Female	20 17.4%	31 26.5%	31 26.3%	82 23.4%
Male	95 82.6%	86 73.5%	87 73.7%	268 76.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 6.1%	9 7.7%	10 8.5%	26 7.4%
Not Hispanic or Latino	108 93.9%	107 91.5%	107 90.7%	322 92%
Unknown or Not Reported	0 0%	1 0.9%	1 0.8%	2 0.6%
Race/Ethnicity, Customized (Count of Participants)
White	28 24.3%	30 25.6%	27 22.9%	85 24.3%
Black or African American	83 72.2%	83 70.9%	88 74.6%	254 72.6%
Asian	1 0.9%	3 2.6%	1 0.8%	5 1.4%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	1 0.9%	1 0.9%	1 0.8%	3 0.9%
Other	2 1.7%	0 0%	1 0.8%	3 0.9%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	90.60 (18.895)	89.01 (20.462)	91.84 (22.885)	90.49 (20.802)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	175.1 (9.09)	174.3 (9.95)	173.1 (10.91)	174.1 (10.02)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.576 (5.938)	29.376 (6.664)	30.706 (7.293)	29.890 (6.667)
Waist-to-Hip Ratio (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	0.947 (0.078)	0.936 (0.072)	0.944 (0.090)	0.942 (0.080)
Previous Antipsychotic Treatment (Count of Participants)
Yes	114 99.1%	116 99.1%	118 100%	348 99.4%
No	1 0.9%	1 0.9%	0 0%	2 0.6%
Age at First Schizophrenia Diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.5 (8.21)	26.9 (8.48)	26.6 (9.25)	26.3 (8.66)

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population

Arm/Group Title	RBP-7000 90 mg	RBP-7000 120 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	111	114	112
Least Squares Mean (Standard Error) [units on a scale]	-15.367 (1.2230)	-16.456 (1.2073)	-9.219 (1.2162)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RBP-7000 90 mg, Placebo
	Comments	Estimates, standard errors (SE), 2-sided confidence intervals (CIs), 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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments	For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.
	Method	repeated measure linear regression model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.148
	Confidence Interval	(2-Sided) 95%; -9.982 to -2.314
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7261
	Estimation Comments	RBP-7000 90 mg - Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	RBP-7000 120 mg, Placebo
	Comments	Estimates, standard errors (SE), 2-sided confidence intervals (CIs), 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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.
	Method	repeated measure linear regression model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.237
	Confidence Interval	(2-Sided) 95%; -11.045 to -3.429
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7141
	Estimation Comments	RBP-7000 120 mg - Placebo

2. Secondary Outcome

Title	Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S)
Description	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

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT)

Arm/Group Title	RBP-7000 90 mg	RBP-7000 120 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	111	114	112
Least Squares Mean (Standard Error) [units on a scale]	-0.868 (0.0662)	-0.914 (0.0654)	-0.518 (0.0659)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RBP-7000 90 mg, Placebo
	Comments	Estimates, standard errors (SE), 2-sided confidence intervals (CIs), 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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.
	Method	repeated measure linear regression model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.350
	Confidence Interval	(2-Sided) 95%; -0.557 to -0.143
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0934
	Estimation Comments	RBP-7000 90 mg - Placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	RBP-7000 120 mg, Placebo
	Comments	Estimates, standard errors (SE), 2-sided confidence intervals (CIs), 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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.
	Method	repeated measure linear regression model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.396
	Confidence Interval	(2-Sided) 95%; -0.602 to -0.190
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0928
	Estimation Comments	RBP-7000 120 mg - Placebo

3. Secondary Outcome

Title	Summary of Participants With Treatment-Emergent Adverse Events (TEAE)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	RBP-7000 90 mg	RBP-7000 120 mg	Placebo
Arm/Group Description	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.	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.	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.
Measure Participants	115	117	118
No TEAEs	34 29.6%	26 22.2%	37 31.4%
1 or more TEAEs	81 70.4%	91 77.8%	81 68.6%
Related TEAE	58 50.4%	65 55.6%	50 42.4%
Serious TEAE	0 0%	1 0.9%	1 0.8%
Serious, related TEAE	0 0%	0 0%	0 0%
TEAE causing discontinuation	0 0%	2 1.7%	3 2.5%
Death	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Day 1 to Week 8
Arm/Group Title	RBP-7000 90 mg		RBP-7000 120 mg		Placebo
Arm/Group Description	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.		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.		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.
All Cause Mortality
	RBP-7000 90 mg		RBP-7000 120 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/115 (0%)		0/117 (0%)		0/118 (0%)
Serious Adverse Events
	RBP-7000 90 mg		RBP-7000 120 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/115 (0%)		1/117 (0.9%)		1/118 (0.8%)
Gastrointestinal disorders
Dyspepsia	0/115 (0%)		0/117 (0%)		1/118 (0.8%)
General disorders
Chest pain	0/115 (0%)		1/117 (0.9%)		0/118 (0%)
Other (Not Including Serious) Adverse Events
	RBP-7000 90 mg		RBP-7000 120 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	65/115 (56.5%)		70/117 (59.8%)		64/118 (54.2%)
Gastrointestinal disorders
Constipation	8/115 (7%)		9/117 (7.7%)		6/118 (5.1%)
Toothache	9/115 (7.8%)		8/117 (6.8%)		7/118 (5.9%)
Dyspepsia	4/115 (3.5%)		7/117 (6%)		11/118 (9.3%)
Nausea	5/115 (4.3%)		6/117 (5.1%)		10/118 (8.5%)
General disorders
Injection site pain	18/115 (15.7%)		26/117 (22.2%)		23/118 (19.5%)
Injection site erythema	7/115 (6.1%)		5/117 (4.3%)		6/118 (5.1%)
Nodule	3/115 (2.6%)		4/117 (3.4%)		6/118 (5.1%)
Investigations
Weight increased	15/115 (13%)		15/117 (12.8%)		4/118 (3.4%)
Musculoskeletal and connective tissue disorders
Back pain	4/115 (3.5%)		8/117 (6.8%)		5/118 (4.2%)
Musculoskeletal pain	6/115 (5.2%)		6/117 (5.1%)		3/118 (2.5%)
Pain in extremity	1/115 (0.9%)		9/117 (7.7%)		6/118 (5.1%)
Nervous system disorders
Headache	20/115 (17.4%)		18/117 (15.4%)		28/118 (23.7%)
Akathisia	3/115 (2.6%)		8/117 (6.8%)		5/118 (4.2%)
Somnolence	6/115 (5.2%)		5/117 (4.3%)		0/118 (0%)
Psychiatric disorders
Anxiety	3/115 (2.6%)		8/117 (6.8%)		6/118 (5.1%)
Insomnia	4/115 (3.5%)		3/117 (2.6%)		7/118 (5.9%)
Skin and subcutaneous tissue disorders
Pruritus	6/115 (5.2%)		5/117 (4.3%)		9/118 (7.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multicenter publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.