Trial Outcomes & Findings for Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia (NCT NCT00694707)
NCT ID: NCT00694707
Last Updated: 2019-06-12
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
732 participants
Primary outcome timeframe
Baseline to Week 6
Results posted on
2019-06-12
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo orally once a day for 6 weeks.
|
Cariprazine 1.5 mg
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
|
Cariprazine 3.0 mg
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
|
Cariprazine 4.5 mg
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
|
Risperidone 4.0 mg
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
145
|
147
|
148
|
141
|
|
Overall Study
COMPLETED
|
79
|
90
|
96
|
98
|
101
|
|
Overall Study
NOT COMPLETED
|
72
|
55
|
51
|
50
|
40
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo orally once a day for 6 weeks.
|
Cariprazine 1.5 mg
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
|
Cariprazine 3.0 mg
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
|
Cariprazine 4.5 mg
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
|
Risperidone 4.0 mg
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Did Not Receive Treatment
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
22
|
14
|
8
|
12
|
13
|
|
Overall Study
Insufficient Therapeutic Response
|
33
|
18
|
17
|
15
|
10
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
3
|
1
|
|
Overall Study
Withdrawal of Consent
|
14
|
18
|
22
|
16
|
15
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Jeopardizing Parole Status
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death in the Family
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Arrest by Police
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Administrative Reasons
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Notification of Past Head Injury
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo
n=151 Participants
Participants received placebo orally once a day for 6 weeks.
|
Cariprazine 1.5 mg
n=145 Participants
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
|
Cariprazine 3.0 mg
n=146 Participants
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
|
Cariprazine 4.5 mg
n=147 Participants
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
|
Risperidone 4.0 mg
n=140 Participants
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
|
Total
n=729 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
36.8 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
37.1 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
35.8 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 11.1 • n=31 Participants
|
36.4 years
STANDARD_DEVIATION 10.5 • n=30 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
227 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
98 Participants
n=31 Participants
|
502 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
145 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
143 Participants
n=7 Participants
|
135 Participants
n=31 Participants
|
705 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
183 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
171 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
370 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Weight
|
74.4 kg
STANDARD_DEVIATION 18.6 • n=99 Participants
|
71.7 kg
STANDARD_DEVIATION 17.7 • n=107 Participants
|
74.8 kg
STANDARD_DEVIATION 16.3 • n=206 Participants
|
72.4 kg
STANDARD_DEVIATION 16.6 • n=7 Participants
|
75.1 kg
STANDARD_DEVIATION 18.2 • n=31 Participants
|
73.7 kg
STANDARD_DEVIATION 17.5 • n=30 Participants
|
|
Height
|
170.8 cm
STANDARD_DEVIATION 11.2 • n=99 Participants
|
169.0 cm
STANDARD_DEVIATION 10.5 • n=107 Participants
|
170.7 cm
STANDARD_DEVIATION 10.3 • n=206 Participants
|
170.3 cm
STANDARD_DEVIATION 10.4 • n=7 Participants
|
170.0 cm
STANDARD_DEVIATION 10.5 • n=31 Participants
|
170.2 cm
STANDARD_DEVIATION 10.6 • n=30 Participants
|
|
Body Mass Index (BMI)
|
25.2 kg/m^2
STANDARD_DEVIATION 4.5 • n=99 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 4.9 • n=107 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 4.6 • n=206 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 4.8 • n=31 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 4.6 • n=30 Participants
|
|
Waist circumference
|
86.7 cm
STANDARD_DEVIATION 12.9 • n=99 Participants
|
85.2 cm
STANDARD_DEVIATION 13.1 • n=107 Participants
|
87.6 cm
STANDARD_DEVIATION 12.6 • n=206 Participants
|
85.8 cm
STANDARD_DEVIATION 12.7 • n=7 Participants
|
88.0 cm
STANDARD_DEVIATION 13.0 • n=31 Participants
|
86.7 cm
STANDARD_DEVIATION 12.9 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-treat population: All participants who took at least 1 dose of double-blind investigational product and who had at least 1 post-baseline assessment of the primary efficacy parameter, the PANSS total score.
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants received placebo orally once a day for 6 weeks.
|
Cariprazine 1.5 mg
n=140 Participants
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
|
Cariprazine 3.0 mg
n=140 Participants
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
|
Cariprazine 4.5 mg
n=145 Participants
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
|
Risperidone 4.0 mg
n=138 Participants
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in the PANSS Total Score
Baseline
|
97.3 Units on a scale
Standard Error 0.8
|
97.1 Units on a scale
Standard Error 0.8
|
97.2 Units on a scale
Standard Error 0.7
|
96.7 Units on a scale
Standard Error 0.8
|
98.1 Units on a scale
Standard Error 0.8
|
|
Change From Baseline to Week 6 in the PANSS Total Score
Change at Week 6
|
-9.5 Units on a scale
Standard Error 1.6
|
-17.3 Units on a scale
Standard Error 1.7
|
-18.7 Units on a scale
Standard Error 1.8
|
-20.2 Units on a scale
Standard Error 1.6
|
-25.3 Units on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-treat population: All participants who took at least 1 dose of double-blind investigational product and who had at least 1 post-baseline assessment of the primary efficacy parameter, the PANSS total score.
The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo
n=148 Participants
Participants received placebo orally once a day for 6 weeks.
|
Cariprazine 1.5 mg
n=140 Participants
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
|
Cariprazine 3.0 mg
n=140 Participants
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
|
Cariprazine 4.5 mg
n=145 Participants
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
|
Risperidone 4.0 mg
n=138 Participants
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in the CGI-S Score
Baseline
|
4.9 Units on a scale
Standard Error 0.1
|
4.7 Units on a scale
Standard Error 0.1
|
4.9 Units on a scale
Standard Error 0.1
|
4.8 Units on a scale
Standard Error 0.1
|
4.8 Units on a scale
Standard Error 0.1
|
|
Change From Baseline to Week 6 in the CGI-S Score
Change at Week 6
|
-0.6 Units on a scale
Standard Error 0.1
|
-0.9 Units on a scale
Standard Error 0.1
|
-1.1 Units on a scale
Standard Error 0.1
|
-1.2 Units on a scale
Standard Error 0.1
|
-1.4 Units on a scale
Standard Error 0.1
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 67 other events
Deaths: 0 deaths
Cariprazine 1.5 mg
Serious events: 5 serious events
Other events: 73 other events
Deaths: 0 deaths
Cariprazine 3.0 mg
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Cariprazine 4.5 mg
Serious events: 4 serious events
Other events: 87 other events
Deaths: 0 deaths
Risperidone 4.0 mg
Serious events: 3 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=151 participants at risk
Participants received placebo orally once a day for 6 weeks.
|
Cariprazine 1.5 mg
n=145 participants at risk
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
|
Cariprazine 3.0 mg
n=146 participants at risk
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
|
Cariprazine 4.5 mg
n=147 participants at risk
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
|
Risperidone 4.0 mg
n=140 participants at risk
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Schizophrenia
|
0.66%
1/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.69%
1/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.68%
1/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.68%
1/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Agitation
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.68%
1/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Investigations
HIV test positive
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.68%
1/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.69%
1/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Fear of needles
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.69%
1/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.69%
1/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.69%
1/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Psychotic behaviour
|
2.0%
3/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.69%
1/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Metabolism and nutrition disorders
Spinal compression fracture
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.69%
1/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.66%
1/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.71%
1/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.71%
1/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Grand mal convulsion
|
0.66%
1/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Psychotic disorder
|
0.66%
1/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.71%
1/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
Other adverse events
| Measure |
Placebo
n=151 participants at risk
Participants received placebo orally once a day for 6 weeks.
|
Cariprazine 1.5 mg
n=145 participants at risk
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
|
Cariprazine 3.0 mg
n=146 participants at risk
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
|
Cariprazine 4.5 mg
n=147 participants at risk
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
|
Risperidone 4.0 mg
n=140 participants at risk
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.3%
5/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
4.8%
7/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
7.5%
11/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
7.5%
11/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
6.4%
9/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
6/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
9.7%
14/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
6.2%
9/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
5.4%
8/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
9.3%
13/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
5/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
2.8%
4/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
6.2%
9/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
5.4%
8/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
2.9%
4/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Investigations
Weight increased
|
0.66%
1/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
2.1%
3/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
3.4%
5/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.00%
0/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
5.0%
7/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Extrapyramidal disorder
|
6.0%
9/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
11.7%
17/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
9.6%
14/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
12.9%
19/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
15.0%
21/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Akathisia
|
5.3%
8/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
9.0%
13/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
9.6%
14/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
8.8%
13/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
8.6%
12/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Headache
|
11.3%
17/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
11.7%
17/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
7.5%
11/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
8.2%
12/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
9.3%
13/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Sedation
|
4.0%
6/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
5.5%
8/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
4.8%
7/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
8.2%
12/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
11.4%
16/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Dizziness
|
2.0%
3/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
3.4%
5/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
2.1%
3/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
6.1%
9/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
5.7%
8/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Tremor
|
4.0%
6/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
3.4%
5/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
4.8%
7/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
2.7%
4/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
7.1%
10/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Insomnia
|
7.3%
11/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
10.3%
15/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
16.4%
24/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
16.3%
24/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
15.0%
21/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Schizophrenia
|
7.9%
12/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
4.1%
6/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
4.8%
7/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
6.1%
9/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
0.71%
1/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Anxiety
|
3.3%
5/151
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
4.1%
6/145
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
5.5%
8/146
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
5.4%
8/147
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
2.1%
3/140
Safety population: All randomized participants who took at least 1 dose of double-blind investigational product.
|
Additional Information
Willie R. Earley, MD Associate Vice President Clinical Development-CNS
Allergan
Phone: 714-246-4500
Email: [email protected]
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