Trial Outcomes & Findings for Brexpiprazole in Patients With Acute Schizophrenia (NCT NCT01810380)
NCT ID: NCT01810380
Last Updated: 2017-03-16
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
COMPLETED
PHASE3
468 participants
Baseline and Week 6
2017-03-16
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
163
|
151
|
154
|
|
Overall Study
Treated
|
161
|
150
|
153
|
|
Overall Study
COMPLETED
|
108
|
113
|
122
|
|
Overall Study
NOT COMPLETED
|
55
|
38
|
32
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Overall Study
Randomised not treated
|
2
|
1
|
1
|
|
Overall Study
Adverse Event
|
11
|
14
|
4
|
|
Overall Study
Lack of Efficacy
|
24
|
10
|
11
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
6
|
|
Overall Study
Administrative or other reasons
|
11
|
13
|
9
|
Baseline Characteristics
Brexpiprazole in Patients With Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo
n=161 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=153 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
Total
n=464 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.85 years
STANDARD_DEVIATION 10.56 • n=5 Participants
|
39.68 years
STANDARD_DEVIATION 10.87 • n=7 Participants
|
41.12 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
40.56 years
STANDARD_DEVIATION 10.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
349 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
52 participants
n=7 Participants
|
56 participants
n=5 Participants
|
158 participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
29 participants
n=5 Participants
|
87 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
43 participants
n=5 Participants
|
37 participants
n=7 Participants
|
35 participants
n=5 Participants
|
115 participants
n=4 Participants
|
|
Time since schizophrenia diagnosis (years)
|
14.15 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
12.88 years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
13.78 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
13.62 years
STANDARD_DEVIATION 9.42 • n=4 Participants
|
|
Time since first antipsychotic treatment (years)
|
14.48 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
13.43 years
STANDARD_DEVIATION 9.19 • n=7 Participants
|
14.31 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
14.08 years
STANDARD_DEVIATION 9.16 • n=4 Participants
|
|
PANSS total score
|
98.38 units on a scale
STANDARD_DEVIATION 10.30 • n=5 Participants
|
97.82 units on a scale
STANDARD_DEVIATION 10.25 • n=7 Participants
|
98.82 units on a scale
STANDARD_DEVIATION 10.83 • n=5 Participants
|
98.34 units on a scale
STANDARD_DEVIATION 10.45 • n=4 Participants
|
|
CGI-S Score
|
4.94 units on a scale
STANDARD_DEVIATION 0.57 • n=5 Participants
|
4.96 units on a scale
STANDARD_DEVIATION 0.59 • n=7 Participants
|
4.98 units on a scale
STANDARD_DEVIATION 0.57 • n=5 Participants
|
4.96 units on a scale
STANDARD_DEVIATION 0.58 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Full-analysis set (FAS)
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Total Score
|
-15.9 units on a scale
Standard Error 1.5
|
-20.0 units on a scale
Standard Error 1.5
|
-24.0 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in CGI-S Score
|
-0.9 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
|
SECONDARY outcome
Timeframe: Week 6Population: FAS
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
CGI-I Score at Week 6
|
3.0 units on a scale
Standard Error 0.1
|
2.7 units on a scale
Standard Error 0.1
|
2.5 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Positive Subscale Score
|
-5.4 units on a scale
Standard Error 0.5
|
-7.0 units on a scale
Standard Error 0.5
|
-8.1 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Negative Subscale Score
|
-3.1 units on a scale
Standard Error 0.4
|
-3.7 units on a scale
Standard Error 0.4
|
-4.5 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score
|
-8.2 units on a scale
Standard Error 0.7
|
-9.9 units on a scale
Standard Error 0.7
|
-11.6 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Excited Component Score
|
-2.5 units on a scale
Standard Error 0.3
|
-3.3 units on a scale
Standard Error 0.3
|
-3.9 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms
|
-3.6 units on a scale
Standard Error 0.4
|
-4.3 units on a scale
Standard Error 0.4
|
-4.8 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms
|
-5.7 units on a scale
Standard Error 0.5
|
-7.1 units on a scale
Standard Error 0.5
|
-8.4 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts
|
-3.2 units on a scale
Standard Error 0.4
|
-4.0 units on a scale
Standard Error 0.4
|
-4.8 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement
|
-1.8 units on a scale
Standard Error 0.3
|
-2.5 units on a scale
Standard Error 0.3
|
-2.8 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS
The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression
|
-2.9 units on a scale
Standard Error 0.2
|
-3.2 units on a scale
Standard Error 0.2
|
-3.6 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: APTS
Discontinuation due to lack of efficacy was based on the primary reason for withdrawal
Outcome measures
| Measure |
Placebo
n=161 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=153 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Discontinuation Due to Lack of Efficacy During the Study
|
14.91 percentage of patients
|
6.67 percentage of patients
|
7.19 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS (last assessment)
The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2
Outcome measures
| Measure |
Placebo
n=159 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=150 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Response Rate at Week 6
|
32.1 percentage of responders
|
48.7 percentage of responders
|
62.7 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS. PSP was collected at Baseline, Day 21 and Day 42 only, due to the windowing only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF.
The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance.
Outcome measures
| Measure |
Placebo
n=139 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=133 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=138 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Change From Baseline to Week 6 in PSP Total Score
|
9.4 units on a scale
Standard Error 1.0
|
13.0 units on a scale
Standard Error 1.0
|
15.3 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Week 6Population: FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.
The PSP functional remission rate was defined as a PSP total score ≥71
Outcome measures
| Measure |
Placebo
n=157 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=146 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=146 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
PSP Functional Remission Rate at Week 6
|
5.7 percentage of remitters
|
9.6 percentage of remitters
|
14.4 percentage of remitters
|
SECONDARY outcome
Timeframe: Week 6Population: FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.
The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score
Outcome measures
| Measure |
Placebo
n=157 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=146 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=146 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
PSP Functional Response Rate at Week 6
|
36.3 percentage of responders
|
53.4 percentage of responders
|
64.4 percentage of responders
|
SECONDARY outcome
Timeframe: Week 6Population: FAS. As this was based on observed cases, only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used.
PSP domain D: disturbing and aggressive behaviours were categorised as "aggressive" (corresponding to mild, manifest, marked, severe, or very severe) or "nonaggressive" (corresponding to absent)
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=114 Participants
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine Extended Release
n=126 Participants
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
PSP Domain D: Disturbing and Aggressive Behaviours at Week 6
|
30.4 percentage of aggressive patients
|
27.2 percentage of aggressive patients
|
22.2 percentage of aggressive patients
|
Adverse Events
Placebo
Brexpiprazole
Quetiapine
Serious adverse events
| Measure |
Placebo
n=161 participants at risk
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 participants at risk
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine
n=153 participants at risk
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.67%
1/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.67%
1/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Anxiety
|
0.62%
1/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Psychotic disorder
|
0.62%
1/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.65%
1/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Schizophrenia
|
2.5%
4/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
2.0%
3/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.65%
1/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.62%
1/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.67%
1/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.67%
1/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
Other adverse events
| Measure |
Placebo
n=161 participants at risk
Placebo: Once daily as tablets and capsules, orally
|
Brexpiprazole
n=150 participants at risk
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
|
Quetiapine
n=153 participants at risk
Active Reference
Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
2/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
1.3%
2/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
8.5%
13/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Weight increased
|
3.7%
6/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
5.3%
8/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
13.1%
20/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Akathisia
|
2.5%
4/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
6.0%
9/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
3.9%
6/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dizziness
|
0.62%
1/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
2.7%
4/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
11.8%
18/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Headache
|
6.8%
11/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
5.3%
8/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
5.9%
9/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Sedation
|
3.1%
5/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
2.7%
4/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
5.2%
8/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Somnolence
|
5.0%
8/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
4.7%
7/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
22.2%
34/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Insomnia
|
6.2%
10/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
8.7%
13/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
2.6%
4/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Schizophrenia
|
6.8%
11/161 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
4.0%
6/150 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
2.6%
4/153 • Baseline to end of treatment (Week 6)
Treatment-Emergent Adverse Events are reported in this section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place