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Safety and Efficacy of Cariprazine in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01104766
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Cariprazine
Drug: Aripiprazole
Drug: Placebo
Enrollment 617
Recruitment Details  
Pre-assignment Details 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
Hide 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
Reason Not Completed
Did not meet inc/exc criteria             1             0             0             0
Adverse Event             17             15             20             14
Lack of Efficacy             20             15             14             8
Protocol Violation             2             0             0             0
Withdrawal by Subject             17             19             25             15
Lost to Follow-up             1             2             1             1
Arm/Group Title Placebo Cariprazine 3.0 mg Cariprazine 6.0mg Aripiprazole 10.0 mg Total
Hide 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 Number of Baseline Participants 153 155 157 152 617
Hide Baseline Analysis Population Description
The randomized population is also the safety population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 155 participants 157 participants 152 participants 617 participants
38.2  (11.3) 37.9  (10.6) 38.6  (10.6) 39.3  (10.8) 38.5  (10.8)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 155 participants 157 participants 152 participants 617 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 155 participants 157 participants 152 participants 617 participants
Hispanic or Latino
3
   2.0%
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 155 participants 157 participants 152 participants 617 participants
White
93
  60.8%
102
  65.8%
101
  64.3%
99
  65.1%
395
  64.0%
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
   0.0%
2
   1.3%
4
   0.6%
Native Hawaiian or Other Pacific Islander
3
   2.0%
1
   0.6%
0
   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
  11.0%
17
  10.8%
16
  10.5%
62
  10.0%
1.Primary Outcome
Title Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Oral administration. Once per day.
Oral administration. Once per day.
Oral administration. Once per day.
Oral administration. Once per day.
Overall Number of Participants Analyzed 149 151 154 150
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-14.3  (1.5) -20.2  (1.5) -23.0  (1.5) -21.2  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 3.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0044
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-10.1 to -1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 6.0mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.8
Confidence Interval (2-Sided) 95%
-12.9 to -4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Aripiprazole 10.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-11.0 to -2.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Oral administration. Once per day.
Oral administration. Once per day.
Oral administration. Once per day.
Oral administration. Once per day.
Overall Number of Participants Analyzed 149 151 154 150
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-1.0  (0.1) -1.4  (0.1) -1.5  (0.1) -1.4  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 3.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.6 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cariprazine 6.0mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.7 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Aripiprazole 10.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.6 to -0.2
Estimation Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/153 (0.00%)   0/155 (0.00%)   2/157 (1.27%)   0/152 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Cariprazine 3.0 mg Cariprazine 6.0mg Aripiprazole 10.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/153 (1.31%)   4/155 (2.58%)   7/157 (4.46%)   4/152 (2.63%) 
Cardiac disorders         
Acute myocardial infarction  1  0/153 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/152 (0.00%) 
Ischemic stroke  1  0/153 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/152 (0.00%) 
Supraventricular tachycardia  1  0/153 (0.00%)  1/155 (0.65%)  0/157 (0.00%)  0/152 (0.00%) 
Injury, poisoning and procedural complications         
Artropod bite * 1  1/153 (0.65%)  0/155 (0.00%)  0/157 (0.00%)  0/152 (0.00%) 
Toxicity to various agents  1  0/153 (0.00%)  0/155 (0.00%)  0/157 (0.00%)  1/152 (0.66%) 
Nervous system disorders         
Transient ischemic attack  1  0/153 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/152 (0.00%) 
Psychiatric disorders         
Schizophrenia, paranoid type  1  0/153 (0.00%)  1/155 (0.65%)  1/157 (0.64%)  0/152 (0.00%) 
Agitation * 1  0/153 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/152 (0.00%) 
Complete Suicide  1  0/153 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/152 (0.00%) 
Psychotic disorder  1  0/153 (0.00%)  2/155 (1.29%)  0/157 (0.00%)  0/152 (0.00%) 
Schizophrenia  1  0/153 (0.00%)  1/155 (0.65%)  0/157 (0.00%)  0/152 (0.00%) 
Depression * 1  0/153 (0.00%)  0/155 (0.00%)  0/157 (0.00%)  1/152 (0.66%) 
Renal and urinary disorders         
Dehydration  1  0/153 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/152 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia  1  1/153 (0.65%)  0/155 (0.00%)  0/157 (0.00%)  0/152 (0.00%) 
Bronchitis  1  0/153 (0.00%)  0/155 (0.00%)  0/157 (0.00%)  1/152 (0.66%) 
Surgical and medical procedures         
Social stay hospitalization  1  0/153 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  1/152 (0.66%) 
1
Term from vocabulary, MedDRA 14.1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Cariprazine 3.0 mg Cariprazine 6.0mg Aripiprazole 10.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   68/153 (44.44%)   61/155 (39.35%)   71/157 (45.22%)   61/152 (40.13%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  3/153 (1.96%)  1/155 (0.65%)  7/157 (4.46%)  9/152 (5.92%) 
Nausea * 1  5/153 (3.27%)  3/155 (1.94%)  5/157 (3.18%)  11/152 (7.24%) 
Infections and infestations         
Vaginal Infection  1  0/56 (0.00%)  3/56 (5.36%)  0/57 (0.00%)  0/58 (0.00%) 
Nervous system disorders         
Akathisia * 1  9/153 (5.88%)  12/155 (7.74%)  24/157 (15.29%)  11/152 (7.24%) 
Headache * 1  17/153 (11.11%)  10/155 (6.45%)  16/157 (10.19%)  15/152 (9.87%) 
Psychiatric disorders         
Insomnia * 1  25/153 (16.34%)  21/155 (13.55%)  22/157 (14.01%)  16/152 (10.53%) 
Anxiety * 1  11/153 (7.19%)  12/155 (7.74%)  12/157 (7.64%)  12/152 (7.89%) 
Agitation * 1  12/153 (7.84%)  3/155 (1.94%)  4/157 (2.55%)  8/152 (5.26%) 
Schizophrenia  1  12/153 (7.84%)  3/155 (1.94%)  4/157 (2.55%)  8/152 (5.26%) 
1
Term from vocabulary, MedDRA 14.1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Allergan
Phone: 877-277-8566
EMail: IR‐CTRegistration@Allergan.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01104766     History of Changes
Other Study ID Numbers: RGH-MD-04
First Submitted: April 9, 2010
First Posted: April 15, 2010
Results First Submitted: June 14, 2018
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018