Trial Outcomes & Findings for Pediatric Schizophrenia Efficacy and Safety Study (NCT NCT01911429)
NCT ID: NCT01911429
Last Updated: 2017-04-18
Results Overview
PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
327 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2017-04-18
Participant Flow
Participant milestones
| Measure |
Lurasidone 40 mg
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit
|
Placebo
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
106
|
113
|
|
Overall Study
COMPLETED
|
96
|
96
|
93
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
20
|
Reasons for withdrawal
| Measure |
Lurasidone 40 mg
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit
|
Placebo
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
9
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
4
|
|
Overall Study
Accidental randomization
|
0
|
0
|
1
|
|
Overall Study
subject left study
|
1
|
0
|
0
|
Baseline Characteristics
Pediatric Schizophrenia Efficacy and Safety Study
Baseline characteristics by cohort
| Measure |
Lurasidone 40 mg
n=110 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=104 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
110 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
326 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 1.33 • n=5 Participants
|
15.3 years
STANDARD_DEVIATION 1.35 • n=7 Participants
|
15.3 years
STANDARD_DEVIATION 1.37 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 1.35 • n=4 Participants
|
|
Age, Customized
13-15 years old
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Age, Customized
16-17 years old
|
60 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
282 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
North America
|
38 participants
n=5 Participants
|
35 participants
n=7 Participants
|
37 participants
n=5 Participants
|
110 participants
n=4 Participants
|
|
Region of Enrollment
South America
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
5 participants
n=5 Participants
|
57 participants
n=7 Participants
|
61 participants
n=5 Participants
|
123 participants
n=4 Participants
|
|
Region of Enrollment
Southeast Asia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
East Asia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Baseline BMI Percentile
< 3th percentile
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Baseline BMI Percentile
> 3th to 85th percentile
|
74 participants
n=5 Participants
|
65 participants
n=7 Participants
|
72 participants
n=5 Participants
|
211 participants
n=4 Participants
|
|
Baseline BMI Percentile
>97th percentile
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Baseline BMI
|
22.38 Kg/m^2
STANDARD_DEVIATION 3.262 • n=5 Participants
|
22.56 Kg/m^2
STANDARD_DEVIATION 3.497 • n=7 Participants
|
22.52 Kg/m^2
STANDARD_DEVIATION 3.606 • n=5 Participants
|
22.48 Kg/m^2
STANDARD_DEVIATION 3.448 • n=4 Participants
|
|
Baseline weight
|
63.5 kg
STANDARD_DEVIATION 12.39 • n=5 Participants
|
63.9 kg
STANDARD_DEVIATION 12.88 • n=7 Participants
|
64.0 kg
STANDARD_DEVIATION 11.88 • n=5 Participants
|
63.8 kg
STANDARD_DEVIATION 12.34 • n=4 Participants
|
|
DSM-IV diagnosis of Schizophrenia
295.10 schizophrenia, disorganized type
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
DSM-IV diagnosis of Schizophrenia
295.30 schizophrenia, paranoid type
|
88 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
DSM-IV diagnosis of Schizophrenia
295.90 schizophrenia, undifferentiated type
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksPopulation: The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.
PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.
Week 6
|
-18.6 units on a scale
Standard Deviation 1.59
|
-18.3 units on a scale
Standard Deviation 1.60
|
-10.5 units on a scale
Standard Deviation 1.59
|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.
baseline
|
94.5 units on a scale
Standard Deviation 10.97
|
94.0 units on a scale
Standard Deviation 11.12
|
92.8 units on a scale
Standard Deviation 11.08
|
SECONDARY outcome
Timeframe: baseline, week 6Population: The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable
Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures- scale from 1-7 - 1=normal, not at all ill; 7=among the most extremely ill patients. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale
baseline
|
4.9 units on a scale
Standard Deviation 0.62
|
4.8 units on a scale
Standard Deviation 0.66
|
4.8 units on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale
week 6
|
-0.97 units on a scale
Standard Deviation 0.093
|
-0.92 units on a scale
Standard Deviation 0.093
|
-0.50 units on a scale
Standard Deviation 0.094
|
SECONDARY outcome
Timeframe: baseline, week 6Population: ITT population
PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures -Positive subscale (range 7-49): sum of Items P1 to P7 in the positive subscale - Higher values of PANSS Positive Subscale Score represent greater severity of illness LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in PANSS Positive Subscale Scores
baseline
|
24.1 units on a scale
Standard Deviation 3.96
|
24.0 units on a scale
Standard Deviation 4.08
|
23.4 units on a scale
Standard Deviation 3.75
|
|
Change From Baseline in PANSS Positive Subscale Scores
week 6
|
-6.3 units on a scale
Standard Deviation 0.51
|
-6.3 units on a scale
Standard Deviation 0.51
|
-3.1 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: baseline, week 6Population: ITT population
PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures - - Negative subscale (range 7-49): sum of Items N1 to N7 in the negative subscale - Higher values of PANSS Negative Subscale Score represent greater severity of illness LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in PANSS Positive, Negative Subscale Scores
baseline
|
24.2 units on a scale
Standard Deviation 4.32
|
24.5 units on a scale
Standard Deviation 4.37
|
24.4 units on a scale
Standard Deviation 4.01
|
|
Change From Baseline in PANSS Positive, Negative Subscale Scores
week 6
|
-4.0 units on a scale
Standard Deviation 0.48
|
-3.8 units on a scale
Standard Deviation 0.49
|
-2.3 units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: week 6Population: ITT Population
PANSS responder analysis over time: achieving \>= 20% reduction from baseline
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6
|
69 number of participants
|
47 number of participants
|
69 number of participants
|
SECONDARY outcome
Timeframe: baseline, week 6Population: ITT population
PQ-LES-Q percentage maximum possible score: summary statistics over time - PQ-LES-Q % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life. LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)
baseline
|
51.3 units on a scale
Standard Deviation 17.26
|
53.6 units on a scale
Standard Deviation 18.50
|
52.5 units on a scale
Standard Deviation 15.67
|
|
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)
week 6
|
5.6 units on a scale
Standard Deviation 1.28
|
6.1 units on a scale
Standard Deviation 1.30
|
0.3 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: baseline, week 6Population: ITT population
Clinician-rated Children's Global Assessment Scale (CGAS) score: summary statistics over time - CGAS is a numeric scale (1 through 100) , where 1 represents the most impaired functioning and 100, superior functioning LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS)
baseline
|
44.2 units on a scale
Standard Deviation 9.33
|
44.6 units on a scale
Standard Deviation 8.11
|
43.9 units on a scale
Standard Deviation 8.34
|
|
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS)
week 6
|
11.3 units on a scale
Standard Deviation 1.16
|
11.9 units on a scale
Standard Deviation 1.18
|
7.5 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: baseline, week 6Population: ITT population
PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures -- General psychopathology (range 16-112): sum of Items G1 to G16 in the general psychopathology subscale -Higher values of PANSS General Psychopathology Subscale Score represent greater severity of illness LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in PANSS General Psychopathology Subscale Scores
baseline
|
46.2 units on a scale
Standard Deviation 6.65
|
45.5 units on a scale
Standard Deviation 7.03
|
45.0 units on a scale
Standard Deviation 6.94
|
|
Change From Baseline in PANSS General Psychopathology Subscale Scores
week 6
|
-8.1 units on a scale
Standard Deviation 0.80
|
-8.1 units on a scale
Standard Deviation 0.81
|
-5.3 units on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: baseline, week 6Population: ITT population
Excitability subscale scores (range 4-28): consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control * Higher values of PANSS Excitability Subscale Score represent greater severity of illness LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction.
Outcome measures
| Measure |
Lurasidone 40 mg
n=108 Participants
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=106 Participants
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 Participants
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Change From Baseline in PANSS Excitability Subscale Scores
baseline
|
10.8 units on a scale
Standard Deviation 2.91
|
11.1 units on a scale
Standard Deviation 3.07
|
10.7 units on a scale
Standard Deviation 3.23
|
|
Change From Baseline in PANSS Excitability Subscale Scores
week 6
|
-0.6 units on a scale
Standard Deviation 0.33
|
-1.7 units on a scale
Standard Deviation 0.33
|
-2.4 units on a scale
Standard Deviation 0.33
|
Adverse Events
Lurasidone 40 mg
Serious events: 4 serious events
Other events: 70 other events
Deaths: 0 deaths
Lurasidone 80 mg
Serious events: 2 serious events
Other events: 67 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone 40 mg
n=110 participants at risk
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=104 participants at risk
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 participants at risk
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Psychiatric disorders
schizophrenia
|
1.8%
2/110 • Number of events 2 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
1.9%
2/104 • Number of events 2 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
6.2%
7/112 • Number of events 7 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Psychiatric disorders
Homicidal Ideation
|
0.91%
1/110 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.00%
0/104 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.00%
0/112 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/110 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.00%
0/104 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.89%
1/112 • Number of events 1 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/110 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.00%
0/104 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.89%
1/112 • Number of events 1 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Gastrointestinal disorders
Diarrhoea
|
0.91%
1/110 • Number of events 1 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.00%
0/104 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
0.00%
0/112 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
Other adverse events
| Measure |
Lurasidone 40 mg
n=110 participants at risk
Lurasidone 40 mg once daily
Lurasidone 40 mg: Lurasidone 40 mg once daily
|
Lurasidone 80 mg
n=104 participants at risk
Lurasidone 80 mg once daily
Lurasidone 80 mg: Lurasidone 80 mg once daily
|
Placebo
n=112 participants at risk
Placebo 40 or 80 mg once daily
Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
9.1%
10/110 • Number of events 10 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
11.5%
12/104 • Number of events 12 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
5.4%
6/112 • Number of events 8 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Nervous system disorders
Headache
|
6.4%
7/110 • Number of events 8 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
10.6%
11/104 • Number of events 15 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
12.5%
14/112 • Number of events 19 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Nervous system disorders
Akathisia
|
9.1%
10/110 • Number of events 12 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
8.7%
9/104 • Number of events 10 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
1.8%
2/112 • Number of events 2 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Nervous system disorders
Sedation
|
5.5%
6/110 • Number of events 6 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
1.9%
2/104 • Number of events 3 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
1.8%
2/112 • Number of events 2 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Gastrointestinal disorders
Nausea
|
12.7%
14/110 • Number of events 20 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
14.4%
15/104 • Number of events 18 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
2.7%
3/112 • Number of events 4 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
9/110 • Number of events 10 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
6.7%
7/104 • Number of events 8 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
1.8%
2/112 • Number of events 2 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Psychiatric disorders
Insomnia
|
5.5%
6/110 • Number of events 6 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
6.7%
7/104 • Number of events 8 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
8.9%
10/112 • Number of events 12 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Psychiatric disorders
Agitation
|
4.5%
5/110 • Number of events 7 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
5.8%
6/104 • Number of events 6 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
4.5%
5/112 • Number of events 5 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
|
Psychiatric disorders
Anxiety
|
10.0%
11/110 • Number of events 14 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
2.9%
3/104 • Number of events 3 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
8.0%
9/112 • Number of events 11 • Treatment-emergent adverse event (TEAE) is defined as an AE with a start date on or after the date of first dose through 7 days after study drug discontinuation (14 days for serious adverse events and deaths) for subjects who complete the double blind study but do not enter into the extension study or early discontinue during the double blind study), or through the last study day of the doubleblind period for subjects continuing into the extension study.
AEs were collected from the time the informed consent is signed to the end of the study. Non-leading questions were used to ask subjects about the possible occurrence of AEs. The investigator then established a diagnosis of the event based on signed, symptoms, and/or other clinical information. Please note that two subjects from the lurasidone 80mg (originally 106) group transferred to the lurasidone 40 mg (originally 108) group
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER