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Brexpiprazole in Patients With Acute Schizophrenia

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ClinicalTrials.gov Identifier: NCT01810380
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : March 29, 2016
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Placebo
Drug: Brexpiprazole
Drug: Quetiapine extended release
Enrollment 468
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description Placebo: Once daily as tablets and capsules, orally Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Period Title: Overall Study
Started 163 151 154
Treated 161 150 153
Completed 108 113 122
Not Completed 55 38 32
Reason Not Completed
Randomised not treated             2             1             1
Adverse Event             11             14             4
Lack of Efficacy             24             10             11
Protocol Violation             1             0             1
Withdrawal by Subject             6             0             6
Administrative or other reasons             11             13             9
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release Total
Hide Arm/Group Description Placebo: Once daily as tablets and capsules, orally Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Total of all reporting groups
Overall Number of Baseline Participants 161 150 153 464
Hide Baseline Analysis Population Description
all-patients-treated set (APTS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 150 participants 153 participants 464 participants
40.85  (10.56) 39.68  (10.87) 41.12  (10.91) 40.56  (10.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 150 participants 153 participants 464 participants
Female
70
  43.5%
66
  44.0%
64
  41.8%
200
  43.1%
Male
91
  56.5%
84
  56.0%
89
  58.2%
264
  56.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 150 participants 153 participants 464 participants
American Indian or Alaska Native
0
   0.0%
1
   0.7%
0
   0.0%
1
   0.2%
Asian
2
   1.2%
1
   0.7%
0
   0.0%
3
   0.6%
Native Hawaiian or Other Pacific Islander
1
   0.6%
0
   0.0%
1
   0.7%
2
   0.4%
Black or African American
35
  21.7%
33
  22.0%
38
  24.8%
106
  22.8%
White
123
  76.4%
113
  75.3%
113
  73.9%
349
  75.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   1.3%
1
   0.7%
3
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 150 participants 153 participants 464 participants
United States 50 52 56 158
Estonia 4 3 4 11
France 1 0 1 2
Poland 5 5 5 15
Romania 14 13 11 38
Serbia 13 11 11 35
Slovakia 1 1 1 3
Ukraine 30 28 29 87
Russian Federation 43 37 35 115
Time since schizophrenia diagnosis (years)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 150 participants 153 participants 464 participants
14.15  (9.35) 12.88  (9.43) 13.78  (9.49) 13.62  (9.42)
Time since first antipsychotic treatment (years)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 150 participants 153 participants 464 participants
14.48  (8.98) 13.43  (9.19) 14.31  (9.34) 14.08  (9.16)
PANSS total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 150 participants 153 participants 464 participants
98.38  (10.30) 97.82  (10.25) 98.82  (10.83) 98.34  (10.45)
[1]
Measure Description: 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. PANSS total score is reported for the full analysis set (FAS); PBO=159, Brex=150, Que=150, and no total value was summarised for reporting
CGI-S Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 150 participants 153 participants 464 participants
4.94  (0.57) 4.96  (0.59) 4.98  (0.57) 4.96  (0.58)
[1]
Measure Description: 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). CGI-S score is reported for the full analysis set (FAS); PBO=159, Brex=150, Que=150, and no total value was summarised for reporting
1.Primary Outcome
Title Change From Baseline to Week 6 in PANSS Total Score
Hide Description 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.
Time Frame Baseline and Week 6
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Full-analysis set (FAS)
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-15.9  (1.5) -20.0  (1.5) -24.0  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Brexpiprazole
Comments The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0560
Comments For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.
Method Mixed Models Analysis
Comments Pooled site, visit, treatment as fixed effects, baseline score as continuous covariate, treatment-by-visit and baseline score-by-visit as interactions
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-8.2 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Quetiapine Extended Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-12.2 to -3.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 6 in CGI-S Score
Hide Description

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).

Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-0.9  (0.1) -1.2  (0.1) -1.4  (0.1)
3.Secondary Outcome
Title CGI-I Score at Week 6
Hide Description

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.

Time Frame Week 6
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Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
3.0  (0.1) 2.7  (0.1) 2.5  (0.1)
4.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Positive Subscale Score
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-5.4  (0.5) -7.0  (0.5) -8.1  (0.5)
5.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Negative Subscale Score
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-3.1  (0.4) -3.7  (0.4) -4.5  (0.4)
6.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-8.2  (0.7) -9.9  (0.7) -11.6  (0.7)
7.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Excited Component Score
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-2.5  (0.3) -3.3  (0.3) -3.9  (0.3)
8.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-3.6  (0.4) -4.3  (0.4) -4.8  (0.4)
9.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-5.7  (0.5) -7.1  (0.5) -8.4  (0.5)
10.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-3.2  (0.4) -4.0  (0.4) -4.8  (0.3)
11.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-1.8  (0.3) -2.5  (0.3) -2.8  (0.3)
12.Secondary Outcome
Title Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Mean (Standard Error)
Unit of Measure: units on a scale
-2.9  (0.2) -3.2  (0.2) -3.6  (0.2)
13.Secondary Outcome
Title Discontinuation Due to Lack of Efficacy During the Study
Hide Description Discontinuation due to lack of efficacy was based on the primary reason for withdrawal
Time Frame Baseline to Week 6
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APTS
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 161 150 153
Measure Type: Number
Unit of Measure: percentage of patients
14.91 6.67 7.19
14.Secondary Outcome
Title Response Rate at Week 6
Hide Description 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
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
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FAS (last assessment)
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 159 150 150
Measure Type: Number
Unit of Measure: percentage of responders
32.1 48.7 62.7
15.Secondary Outcome
Title Change From Baseline to Week 6 in PSP Total Score
Hide Description 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.
Time Frame Baseline and Week 6
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Hide Analysis Population Description
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.
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 139 133 138
Mean (Standard Error)
Unit of Measure: units on a scale
9.4  (1.0) 13.0  (1.0) 15.3  (1.0)
16.Secondary Outcome
Title PSP Functional Remission Rate at Week 6
Hide Description The PSP functional remission rate was defined as a PSP total score ≥71
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 157 146 146
Measure Type: Number
Unit of Measure: percentage of remitters
5.7 9.6 14.4
17.Secondary Outcome
Title PSP Functional Response Rate at Week 6
Hide Description The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 157 146 146
Measure Type: Number
Unit of Measure: percentage of responders
36.3 53.4 64.4
18.Secondary Outcome
Title PSP Domain D: Disturbing and Aggressive Behaviours at Week 6
Hide Description 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)
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Brexpiprazole Quetiapine Extended Release
Hide Arm/Group Description:
Placebo: Once daily as tablets and capsules, orally
Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

Overall Number of Participants Analyzed 112 114 126
Measure Type: Number
Unit of Measure: percentage of aggressive patients
30.4 27.2 22.2
Time Frame Baseline to end of treatment (Week 6)
Adverse Event Reporting Description Treatment-Emergent Adverse Events are reported in this section
 
Arm/Group Title Placebo Brexpiprazole Quetiapine
Hide Arm/Group Description Placebo: Once daily as tablets and capsules, orally Brexpiprazole: 2-4 mg/day, once daily, tablets, orally

Active Reference

Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally

All-Cause Mortality
Placebo Brexpiprazole Quetiapine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Brexpiprazole Quetiapine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/161 (3.73%)   7/150 (4.67%)   2/153 (1.31%) 
Metabolism and nutrition disorders       
Type 2 diabetes mellitus  1  0/161 (0.00%)  1/150 (0.67%)  0/153 (0.00%) 
Nervous system disorders       
Grand mal convulsion  1  0/161 (0.00%)  1/150 (0.67%)  0/153 (0.00%) 
Psychiatric disorders       
Anxiety  1  1/161 (0.62%)  0/150 (0.00%)  0/153 (0.00%) 
Psychotic disorder  1  1/161 (0.62%)  0/150 (0.00%)  1/153 (0.65%) 
Schizophrenia  1  4/161 (2.48%)  3/150 (2.00%)  1/153 (0.65%) 
Schizophrenia, paranoid type  1  1/161 (0.62%)  0/150 (0.00%)  0/153 (0.00%) 
Suicide attempt  1  0/161 (0.00%)  1/150 (0.67%)  0/153 (0.00%) 
Skin and subcutaneous tissue disorders       
Angioedema  1  0/161 (0.00%)  1/150 (0.67%)  0/153 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Brexpiprazole Quetiapine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/161 (27.33%)   48/150 (32.00%)   73/153 (47.71%) 
Gastrointestinal disorders       
Dry mouth  1  2/161 (1.24%)  2/150 (1.33%)  13/153 (8.50%) 
Investigations       
Weight increased  1  6/161 (3.73%)  8/150 (5.33%)  20/153 (13.07%) 
Nervous system disorders       
Akathisia  1  4/161 (2.48%)  9/150 (6.00%)  6/153 (3.92%) 
Dizziness  1  1/161 (0.62%)  4/150 (2.67%)  18/153 (11.76%) 
Headache  1  11/161 (6.83%)  8/150 (5.33%)  9/153 (5.88%) 
Sedation  1  5/161 (3.11%)  4/150 (2.67%)  8/153 (5.23%) 
Somnolence  1  8/161 (4.97%)  7/150 (4.67%)  34/153 (22.22%) 
Psychiatric disorders       
Insomnia  1  10/161 (6.21%)  13/150 (8.67%)  4/153 (2.61%) 
Schizophrenia  1  11/161 (6.83%)  6/150 (4.00%)  4/153 (2.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Email contact via
Organization: H. Lundbeck A/S
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01810380     History of Changes
Other Study ID Numbers: 14644A
2012-002252-17 ( EudraCT Number )
First Submitted: March 11, 2013
First Posted: March 13, 2013
Results First Submitted: December 30, 2015
Results First Posted: March 29, 2016
Last Update Posted: March 16, 2017