Safety and Efficacy of Cariprazine in Patients With Schizophrenia

• Sponsor: Forest Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01104766
• Collaborator: Gedeon Richter Ltd. (Industry)
• Enrollment: 617
• Locations: 58
• Arms: 4
• Actual Duration (Months): 19.9
• Patients Per Site: 10.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Cariprazine; Drug: Aripiprazole; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 617 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
• Actual Study Start Date: Apr 23, 2010
• Actual Primary Completion Date: Dec 20, 2011
• Actual Study Completion Date: Dec 20, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cariprazine 3mg Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.	Drug: Cariprazine; Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Other Names: RGH-188
Experimental: Cariprazine 6mg Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.	Drug: Cariprazine; Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Other Names: RGH-188
Active Comparator: Aripiprazole 10mg Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.	Drug: Aripiprazole; Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Placebo Comparator: Placebo Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.	Drug: Placebo; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Outcome Measures

Primary Outcome Measures

1. Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. [Baseline to Week 6]

   The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.

Secondary Outcome Measures

1. Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S) [Baseline to Week 6]

   The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who have provided informed consent prior to any study specific procedures

• Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)

• Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

• Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1

• Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120

• CGI-S score ≥ 4

Exclusion Criteria:

• Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

• Bipolar I and II disorder

• Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders

• DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study

• Women who are pregnant or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woodland International Research Group, Inc.	Little Rock	Arkansas	United States	72211
2	Woodland Research Northwest, LLC	Springdale	Arkansas	United States	72764
3	Synergy Clinical Research of Escondido	Escondido	California	United States	92025
4	Excell Research, Inc	Oceanside	California	United States	92056
5	Clinical Innovations, Inc.	Riverside	California	United States	92506
6	Sharp Mesa Vista Hospital	San Diego	California	United States	92123
7	Collaborative Neuroscience Network, Inc.	Torrance	California	United States	90502
8	Colorado Clinical Trials, Inc.	Littleton	Colorado	United States	80130
9	Comprehensive Clinical Development, Inc.	Washington	District of Columbia	United States	20016
10	Florida Clinical Research Center, LLC	Bradenton	Florida	United States	34208
11	Hawaii Clinical Research Center	Honolulu	Hawaii	United States	96813
12	Uptown Research Institute, LLC	Chicago	Illinois	United States	60640
13	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois	United States	60169
14	Precise Research Centers	Flowood	Mississippi	United States	39232
15	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri	United States	63141
16	CRI Worldwide, LLC	Willingboro	New Jersey	United States	08046
17	Windsor-Laurelwood Center for Behavioral Medicine	Willoughby	Ohio	United States	44094
18	Vanderbilt Psychiatric Hospital	Nashville	Tennessee	United States	37212
19	Claghorn-Lesem Research Clinic, Ltd.	Houston	Texas	United States	77008
20	Pacific Institute of Medical Sciences	Bothell	Washington	United States	98011
21	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie	Bucuresti		Romania	041914
22	Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie	Bucuresti		Romania	41914
23	Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie	Bucuresti		Romania	41914
24	Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III	Cluj-Napoca		Romania	400012
25	Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie	Craiova		Romania	200620
26	Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie	Craiova		Romania	200745
27	Spitalul Judetean de Urgenta Piatra Neamt	Piatra Neamt		Romania	610136
28	Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie	Pitesti		Romania	110069
29	Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu	Sibiu		Romania	550082
30	Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie	Targoviste		Romania	130086
31	Spitalul Clinic Judetean Mures, Clinica Psihiatrie I	Targu Mures		Romania	540142
32	Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"	Timisoara		Romania	300736
33	Healthcare Institution "Moscow Regional Mental Hospital #5"	Orekhovo-Zuyevo	Moscow Region	Russian Federation	142601
34	State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>	Arkhangelsk		Russian Federation	163530
35	State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"	Chelyabinsk		Russian Federation	454087
36	State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"	Chita		Russian Federation	672090
37	St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"	Gatchina		Russian Federation	188357
38	Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"	Saratov		Russian Federation	410028
39	State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"	Saratov		Russian Federation	410060
40	St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"	St. Petersburg		Russian Federation	190121
41	Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients	St. Petersburg		Russian Federation	192019
42	State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"	St. Petersburg		Russian Federation	192019
43	Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Minitstry of Health and Social Development of the Russian Federation	St. Petersburg		Russian Federation	1922019
44	St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"	St. Petersburg		Russian Federation	193167
45	St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7	St. Petersburg		Russian Federation	197341
46	Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"	Tomsk		Russian Federation	634014
47	Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14	Village Glevakha	Kyiv	Ukraine	08613
48	I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology	Dnipropetrovsk		Ukraine	49005
49	Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology	Dnipropetrovsk		Ukraine	49027
50	Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology	Donetsk		Ukraine	83008
51	Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14	Kharkiv		Ukraine	61068
52	State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology	Kharkiv		Ukraine	61068
53	Kherson Regional Psychiatric Hospital, Department #3	Kherson		Ukraine	73488
54	Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions	Kyiv		Ukraine	04080
55	Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)	Lviv		Ukraine	79021
56	O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology	Poltava		Ukraine	36006
57	Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology	Simferopol		Ukraine	95006
58	O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology	Vinnytsya		Ukraine	49005

Sponsors and Collaborators

• Forest Laboratories
• Gedeon Richter Ltd.

Investigators

• Study Director: Raffaele Migliore, MA, Forest Laboratories

Study Documents (Full-Text)

None provided.

More Information

Publications

• Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192.
• Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.
• Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Németh G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.

• Responsible Party: Forest Laboratories
• ClinicalTrials.gov Identifier: NCT01104766
• Other Study ID Numbers: RGH-MD-04
• First Posted: Apr 15, 2010
• Last Update Posted: Oct 29, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Forest Laboratories: Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Aripiprazole; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents
• Additional relevant MeSH terms: Schizophrenia; Aripiprazole; Cariprazine

Study Results

Participant Flow

Pre-assignment Detail	Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. No-drug washout period of up to 7 days.

Arm/Group Title	Placebo	Cariprazine 3.0 mg	Cariprazine 6.0mg	Aripiprazole 10.0 mg
Arm/Group Description	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.
Period Title: Overall Study
STARTED	153	155	157	152
COMPLETED	95	104	97	114
NOT COMPLETED	58	51	60	38

Baseline Characteristics

Arm/Group Title	Placebo	Cariprazine 3.0 mg	Cariprazine 6.0mg	Aripiprazole 10.0 mg	Total
Arm/Group Description	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.	Total of all reporting groups
Overall Participants	153	155	157	152	617
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.2 (11.3)	37.9 (10.6)	38.6 (10.6)	39.3 (10.8)	38.5 (10.8)
Sex/Gender, Customized (Count of Participants)
Male	97 63.4%	99 63.9%	100 63.7%	94 61.8%	390 63.2%
Female	56 36.6%	56 36.1%	57 36.3%	58 38.2%	227 36.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2%	2 1.3%	5 3.2%	2 1.3%	12 1.9%
Not Hispanic or Latino	137 89.5%	134 86.5%	133 84.7%	134 88.2%	538 87.2%
Unknown or Not Reported	13 8.5%	19 12.3%	19 12.1%	16 10.5%	67 10.9%
Race/Ethnicity, Customized (Count of Participants)
White	93 60.8%	102 65.8%	101 64.3%	99 65.1%	395 64%
Black or African-American	42 27.5%	32 20.6%	36 22.9%	33 21.7%	143 23.2%
Asian	1 0.7%	1 0.6%	0 0%	2 1.3%	4 0.6%
Native Hawaiian or Other Pacific Islander	3 2%	1 0.6%	0 0%	1 0.7%	5 0.8%
Other	2 1.3%	2 1.3%	3 1.9%	1 0.7%	8 1.3%
Missing	12 7.8%	17 11%	17 10.8%	16 10.5%	62 10%

Outcome Measures

1. Primary Outcome

Title	Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
Description	The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.

Arm/Group Title	Placebo	Cariprazine 3.0 mg	Cariprazine 6.0mg	Aripiprazole 10.0 mg
Arm/Group Description	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.
Measure Participants	149	151	154	150
Least Squares Mean (Standard Error) [Units on a Scale]	-14.3 (1.5)	-20.2 (1.5)	-23.0 (1.5)	-21.2 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Cariprazine 3.0 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0044
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -10.1 to -1.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Cariprazine 6.0mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.8
	Confidence Interval	(2-Sided) 95%; -12.9 to -4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Aripiprazole 10.0 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Description	The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.

Arm/Group Title	Placebo	Cariprazine 3.0 mg	Cariprazine 6.0mg	Aripiprazole 10.0 mg
Arm/Group Description	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.	Oral administration. Once per day.
Measure Participants	149	151	154	150
Least Squares Mean (Standard Error) [Units on a Scale]	-1.0 (0.1)	-1.4 (0.1)	-1.5 (0.1)	-1.4 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Cariprazine 3.0 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.6 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Cariprazine 6.0mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -0.7 to -0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Aripiprazole 10.0 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -0.6 to -0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Assessed over 2 months
Adverse Event Reporting Description	Data is for the Double-blinding treatment period
Arm/Group Title	Placebo		Cariprazine 3.0 mg		Cariprazine 6.0mg		Aripiprazole 10.0 mg
Arm/Group Description	Oral administration. Once per day.		Oral administration. Once per day.		Oral administration. Once per day.		Oral administration. Once per day.
All Cause Mortality
	Placebo		Cariprazine 3.0 mg		Cariprazine 6.0mg		Aripiprazole 10.0 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/153 (0%)		0/155 (0%)		2/157 (1.3%)		0/152 (0%)
Serious Adverse Events
	Placebo		Cariprazine 3.0 mg		Cariprazine 6.0mg		Aripiprazole 10.0 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/153 (1.3%)		4/155 (2.6%)		7/157 (4.5%)		4/152 (2.6%)
Cardiac disorders
Acute myocardial infarction	0/153 (0%)		0/155 (0%)		1/157 (0.6%)		0/152 (0%)
Ischemic stroke	0/153 (0%)		0/155 (0%)		1/157 (0.6%)		0/152 (0%)
Supraventricular tachycardia	0/153 (0%)		1/155 (0.6%)		0/157 (0%)		0/152 (0%)
Injury, poisoning and procedural complications
Artropod bite	1/153 (0.7%)		0/155 (0%)		0/157 (0%)		0/152 (0%)
Toxicity to various agents	0/153 (0%)		0/155 (0%)		0/157 (0%)		1/152 (0.7%)
Nervous system disorders
Transient ischemic attack	0/153 (0%)		0/155 (0%)		1/157 (0.6%)		0/152 (0%)
Psychiatric disorders
Schizophrenia, paranoid type	0/153 (0%)		1/155 (0.6%)		1/157 (0.6%)		0/152 (0%)
Agitation	0/153 (0%)		0/155 (0%)		1/157 (0.6%)		0/152 (0%)
Complete Suicide	0/153 (0%)		0/155 (0%)		1/157 (0.6%)		0/152 (0%)
Psychotic disorder	0/153 (0%)		2/155 (1.3%)		0/157 (0%)		0/152 (0%)
Schizophrenia	0/153 (0%)		1/155 (0.6%)		0/157 (0%)		0/152 (0%)
Depression	0/153 (0%)		0/155 (0%)		0/157 (0%)		1/152 (0.7%)
Renal and urinary disorders
Dehydration	0/153 (0%)		0/155 (0%)		1/157 (0.6%)		0/152 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/153 (0.7%)		0/155 (0%)		0/157 (0%)		0/152 (0%)
Bronchitis	0/153 (0%)		0/155 (0%)		0/157 (0%)		1/152 (0.7%)
Surgical and medical procedures
Social stay hospitalization	0/153 (0%)		0/155 (0%)		1/157 (0.6%)		1/152 (0.7%)
Other (Not Including Serious) Adverse Events
	Placebo		Cariprazine 3.0 mg		Cariprazine 6.0mg		Aripiprazole 10.0 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/153 (44.4%)		61/155 (39.4%)		71/157 (45.2%)		61/152 (40.1%)
Gastrointestinal disorders
Abdominal discomfort	3/153 (2%)		1/155 (0.6%)		7/157 (4.5%)		9/152 (5.9%)
Nausea	5/153 (3.3%)		3/155 (1.9%)		5/157 (3.2%)		11/152 (7.2%)
Infections and infestations
Vaginal Infection	0/56 (0%)		3/56 (5.4%)		0/57 (0%)		0/58 (0%)
Nervous system disorders
Akathisia	9/153 (5.9%)		12/155 (7.7%)		24/157 (15.3%)		11/152 (7.2%)
Headache	17/153 (11.1%)		10/155 (6.5%)		16/157 (10.2%)		15/152 (9.9%)
Psychiatric disorders
Insomnia	25/153 (16.3%)		21/155 (13.5%)		22/157 (14%)		16/152 (10.5%)
Anxiety	11/153 (7.2%)		12/155 (7.7%)		12/157 (7.6%)		12/152 (7.9%)
Agitation	12/153 (7.8%)		3/155 (1.9%)		4/157 (2.5%)		8/152 (5.3%)
Schizophrenia	12/153 (7.8%)		3/155 (1.9%)		4/157 (2.5%)		8/152 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.