Trial Outcomes & Findings for Safety and Efficacy of Cariprazine in Patients With Schizophrenia (NCT NCT01104766)
NCT ID: NCT01104766
Last Updated: 2018-10-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
617 participants
Primary outcome timeframe
Baseline to Week 6
Results posted on
2018-10-29
Participant Flow
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.
Participant milestones
| Measure |
Placebo
Oral administration. Once per day.
|
Cariprazine 3.0 mg
Oral administration. Once per day.
|
Cariprazine 6.0mg
Oral administration. Once per day.
|
Aripiprazole 10.0 mg
Oral administration. Once per day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
153
|
155
|
157
|
152
|
|
Overall Study
COMPLETED
|
95
|
104
|
97
|
114
|
|
Overall Study
NOT COMPLETED
|
58
|
51
|
60
|
38
|
Reasons for withdrawal
| Measure |
Placebo
Oral administration. Once per day.
|
Cariprazine 3.0 mg
Oral administration. Once per day.
|
Cariprazine 6.0mg
Oral administration. Once per day.
|
Aripiprazole 10.0 mg
Oral administration. Once per day.
|
|---|---|---|---|---|
|
Overall Study
Did not meet inc/exc criteria
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
17
|
15
|
20
|
14
|
|
Overall Study
Lack of Efficacy
|
20
|
15
|
14
|
8
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
17
|
19
|
25
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo
n=153 Participants
Oral administration. Once per day.
|
Cariprazine 3.0 mg
n=155 Participants
Oral administration. Once per day.
|
Cariprazine 6.0mg
n=157 Participants
Oral administration. Once per day.
|
Aripiprazole 10.0 mg
n=152 Participants
Oral administration. Once per day.
|
Total
n=617 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.2 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
37.9 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
38.6 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
39.3 Years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
38.5 Years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex/Gender, Customized
Male
|
97 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
390 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
227 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
538 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
93 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
395 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.
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.
Outcome measures
| Measure |
Placebo
n=149 Participants
Oral administration. Once per day.
|
Cariprazine 3.0 mg
n=151 Participants
Oral administration. Once per day.
|
Cariprazine 6.0mg
n=154 Participants
Oral administration. Once per day.
|
Aripiprazole 10.0 mg
n=150 Participants
Oral administration. Once per day.
|
|---|---|---|---|---|
|
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
|
-14.3 Units on a Scale
Standard Error 1.5
|
-20.2 Units on a Scale
Standard Error 1.5
|
-23.0 Units on a Scale
Standard Error 1.5
|
-21.2 Units on a Scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.
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.
Outcome measures
| Measure |
Placebo
n=149 Participants
Oral administration. Once per day.
|
Cariprazine 3.0 mg
n=151 Participants
Oral administration. Once per day.
|
Cariprazine 6.0mg
n=154 Participants
Oral administration. Once per day.
|
Aripiprazole 10.0 mg
n=150 Participants
Oral administration. Once per day.
|
|---|---|---|---|---|
|
Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
|
-1.0 Units on a Scale
Standard Error 0.1
|
-1.4 Units on a Scale
Standard Error 0.1
|
-1.5 Units on a Scale
Standard Error 0.1
|
-1.4 Units on a Scale
Standard Error 0.1
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 68 other events
Deaths: 0 deaths
Cariprazine 3.0 mg
Serious events: 4 serious events
Other events: 61 other events
Deaths: 0 deaths
Cariprazine 6.0mg
Serious events: 7 serious events
Other events: 71 other events
Deaths: 2 deaths
Aripiprazole 10.0 mg
Serious events: 4 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=153 participants at risk
Oral administration. Once per day.
|
Cariprazine 3.0 mg
n=155 participants at risk
Oral administration. Once per day.
|
Cariprazine 6.0mg
n=157 participants at risk
Oral administration. Once per day.
|
Aripiprazole 10.0 mg
n=152 participants at risk
Oral administration. Once per day.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.65%
1/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Agitation
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Complete Suicide
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Renal and urinary disorders
Dehydration
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Cardiac disorders
Ischemic stroke
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Surgical and medical procedures
Social stay hospitalization
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.66%
1/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.64%
1/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
1.3%
2/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.65%
1/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.65%
1/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Injury, poisoning and procedural complications
Artropod bite
|
0.65%
1/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.65%
1/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.66%
1/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Depression
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.66%
1/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.66%
1/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
Other adverse events
| Measure |
Placebo
n=153 participants at risk
Oral administration. Once per day.
|
Cariprazine 3.0 mg
n=155 participants at risk
Oral administration. Once per day.
|
Cariprazine 6.0mg
n=157 participants at risk
Oral administration. Once per day.
|
Aripiprazole 10.0 mg
n=152 participants at risk
Oral administration. Once per day.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
3/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.65%
1/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
4.5%
7/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
5.9%
9/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Gastrointestinal disorders
Nausea
|
3.3%
5/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
1.9%
3/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
3.2%
5/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
7.2%
11/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/56 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
5.4%
3/56 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/57 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
0.00%
0/58 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Nervous system disorders
Akathisia
|
5.9%
9/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
7.7%
12/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
15.3%
24/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
7.2%
11/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Nervous system disorders
Headache
|
11.1%
17/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
6.5%
10/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
10.2%
16/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
9.9%
15/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Insomnia
|
16.3%
25/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
13.5%
21/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
14.0%
22/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
10.5%
16/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Anxiety
|
7.2%
11/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
7.7%
12/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
7.6%
12/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
7.9%
12/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Agitation
|
7.8%
12/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
1.9%
3/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
2.5%
4/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
5.3%
8/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
|
Psychiatric disorders
Schizophrenia
|
7.8%
12/153 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
1.9%
3/155 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
2.5%
4/157 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
5.3%
8/152 • Assessed over 2 months
Data is for the Double-blinding treatment period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER