Trial Outcomes & Findings for Pediatric Open-Label Extension Study (NCT NCT01914393)

NCT ID: NCT01914393

Last Updated: 2019-12-19

Results Overview

The Safety population consists of all subjects who received at least one dose of study drug in this study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 702 participants
• Primary outcome timeframe: During 104 Weeks (2-years) treatment period
• Results posted on: 2019-12-19

Participant Flow

participation in the preceding double-blind efficacy and safety studies (D1050301, NCT01911429,; D1050325, NCT01911442; or D1050326, NCT02046369) were eligible for enrollment in this study.

Treatment groups in study D1050301: Placebo, Lurasidone 40 mg/day, Lurasidone 80 mg/day. Treatment groups in study D1050325: Placebo, Lurasidone 20 mg/day, Lurasidone 60 mg/day Treatment groups in study D1050326: Placebo, Lurasidone 20-80 mg/day

Participant milestones

Measure	Rollover From D1050301 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
Overall Study STARTED	271	125	306
Overall Study COMPLETED	156	54	168
Overall Study NOT COMPLETED	115	71	138

Reasons for withdrawal

Measure	Rollover From D1050301 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
Overall Study Protocol Violation	11	3	19
Overall Study Lack of Efficacy	11	16	5
Overall Study no reason given	14	8	16
Overall Study Adverse Event	29	18	31
Overall Study Withdrawal by Subject	38	20	47
Overall Study Lost to Follow-up	12	6	19
Overall Study subject never dosed	0	0	1

Baseline Characteristics

Pediatric Open-Label Extension Study

Baseline characteristics by cohort

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Total n=701 Participants Total of all reporting groups
Age, Continuous	15.5 years STANDARD_DEVIATION 1.44 • n=5 Participants	11.1 years STANDARD_DEVIATION 3.12 • n=7 Participants	14.4 years STANDARD_DEVIATION 2.18 • n=5 Participants	14.3 years STANDARD_DEVIATION 2.66 • n=4 Participants
Age, Customized Children (2-11 years)	0 participants n=5 Participants	75 participants n=7 Participants	36 participants n=5 Participants	111 participants n=4 Participants
Age, Customized Adolescents (12-17 years)	257 participants n=5 Participants	50 participants n=7 Participants	258 participants n=5 Participants	565 participants n=4 Participants
Age, Customized Adults (18-64 years)	14 participants n=5 Participants	0 participants n=7 Participants	11 participants n=5 Participants	25 participants n=4 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	23 Participants n=7 Participants	152 Participants n=5 Participants	276 Participants n=4 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	102 Participants n=7 Participants	153 Participants n=5 Participants	425 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants	21 Participants n=7 Participants	54 Participants n=5 Participants	111 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	235 Participants n=5 Participants	104 Participants n=7 Participants	251 Participants n=5 Participants	590 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	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	23 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	38 Participants n=5 Participants	21 Participants n=7 Participants	26 Participants n=5 Participants	85 Participants n=4 Participants
Race (NIH/OMB) White	197 Participants n=5 Participants	96 Participants n=7 Participants	235 Participants n=5 Participants	528 Participants n=4 Participants
Race (NIH/OMB) More than one race	25 Participants n=5 Participants	4 Participants n=7 Participants	32 Participants n=5 Participants	61 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	82 Participants n=5 Participants	125 Participants n=7 Participants	125 Participants n=5 Participants	332 Participants n=4 Participants
Region of Enrollment South America	21 Participants n=5 Participants	0 Participants n=7 Participants	40 Participants n=5 Participants	61 Participants n=4 Participants
Region of Enrollment Europe	157 Participants n=5 Participants	0 Participants n=7 Participants	131 Participants n=5 Participants	288 Participants n=4 Participants
Region of Enrollment Asia	11 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants

PRIMARY outcome

Timeframe: During 104 Weeks (2-years) treatment period

Population: The Safety population consists of all subjects who received at least one dose of study drug in this study.

The Safety population consists of all subjects who received at least one dose of study drug in this study.

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) n=701 Participants L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) Subjects with at least one treatment emergent AE	214 Participants	106 Participants	252 Participants	572 Participants
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) Subjects with at least one treatment emergent SAE	28 Participants	13 Participants	37 Participants	78 Participants
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) Subjects with AE Leading to Discontinuation	28 Participants	18 Participants	31 Participants	77 Participants

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score for subjects continued from study D1050301.

PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210 Higher values of PANSS total score represents greater severity of illness.

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score Week 28	-11.9 units on a scale Standard Deviation 13.74	—	—	—
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score Open Label Baseline	76.0 units on a scale Standard Deviation 17.72	—	—	—
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score Week 52	-15.6 units on a scale Standard Deviation 14.97	—	—	—
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score Week 104	-18.4 units on a scale Standard Deviation 16.73	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in PANSS Positive Subscale Score for subjects continued from study D1050301 The Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness /persecution, and hostility; Positive subscale (range 7-49) is calculated as sum of Items P1 to P7 in the positive subscale Higher values of PANSS sub-scale scores represent greater severity

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in PANSS Positive Subscale Score Week 52	-5.1 units on a scale Standard Deviation 5.13	—	—	—
Change From Baseline in PANSS Positive Subscale Score Open Label baseline	17.9 units on a scale Standard Deviation 5.51	—	—	—
Change From Baseline in PANSS Positive Subscale Score Week 28	-3.9 units on a scale Standard Deviation 4.68	—	—	—
Change From Baseline in PANSS Positive Subscale Score Week 104	-5.4 units on a scale Standard Deviation 5.66	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in PANSS Negative Subscale Score for subjects continued from study D1050301 The Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; Negative subscale (range 7-49) is calculated as sum of Items N1 to N7 in the negative subscale Higher values of PANSS sub-scale scores represent greater severity of illness.

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in PANSS Negative Subscale Score Open Label baseline	20.5 units on a scale Standard Deviation 4.91	—	—	—
Change From Baseline in PANSS Negative Subscale Score Week 28	-2.6 units on a scale Standard Deviation 4.16	—	—	—
Change From Baseline in PANSS Negative Subscale Score Week 52	-3.4 units on a scale Standard Deviation 4.34	—	—	—
Change From Baseline in PANSS Negative Subscale Score Week 104	-4.3 units on a scale Standard Deviation 4.77	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050301

Change from Baseline in PANSS General Psychopathology Subscale Score for subjects continued from study D1050301 The General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation; General psychopathology subscale (range 16-112) is calculated as sum of Items G1 to G16 in the general psychopathology subscale Higher values of PANSS sub-scale scores represent greater severity of illness.

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in PANSS General Psychopathology Subscale Score Week 52	-7.2 units on a scale Standard Deviation 7.65	—	—	—
Change From Baseline in PANSS General Psychopathology Subscale Score Week 104	-8.7 units on a scale Standard Deviation 8.68	—	—	—
Change From Baseline in PANSS General Psychopathology Subscale Score Open label baseline	37.5 units on a scale Standard Deviation 9.38	—	—	—
Change From Baseline in PANSS General Psychopathology Subscale Score Week 28	-5.4 units on a scale Standard Deviation 7.28	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050301

Change from Baseline in PANSS Excitability Subscale Score for subjects continued from study D1050301 Subscale of Excitability consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control. The sum of the four items ranges from 4 to 28 Higher values of PANSS sub-scale scores represent greater severity of illness.

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in PANSS Excitability Subscale Score Open label baseline	9.0 units on a scale Standard Deviation 3.73	—	—	—
Change From Baseline in PANSS Excitability Subscale Score Week 28	-1.3 units on a scale Standard Deviation 3.09	—	—	—
Change From Baseline in PANSS Excitability Subscale Score Week 52	-1.7 units on a scale Standard Deviation 3.31	—	—	—
Change From Baseline in PANSS Excitability Subscale Score week 104	-2.1 units on a scale Standard Deviation 3.63	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050301

Change from Baseline in the Clinical Global Impression -Severity Score for subjects continued from study D1050301 The CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1='Normal, not at all ill' to 7='Among the most extremely ill patients'. A higher score is associated with greater illness severity

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in the Clinical Global Impression -Severity Score Week 104	-1.31 units on a scale Standard Deviation 1.196	—	—	—
Change From Baseline in the Clinical Global Impression -Severity Score Open label baseline	4.0 units on a scale Standard Deviation 0.97	—	—	—
Change From Baseline in the Clinical Global Impression -Severity Score Week 28	-0.87 units on a scale Standard Deviation 0.941	—	—	—
Change From Baseline in the Clinical Global Impression -Severity Score Week 52	-1.10 units on a scale Standard Deviation 1.084	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score for subjects continued from study D1050301 The Children's Global Assessment Scale (CGAS) is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children under the age of 18, where 1 represents the most impaired functioning and 100, superior functioning. Each decile (e.g., 1-10, 11-20) has a descriptive header (e.g., "Moderate impairment in functioning in most domains") and examples of behaviors and types of environmental accommodations that might be seen at that level of functioning. Scores above 70 on the CGAS indicate functioning within the range of typically developing children of the same age as the child being rated while scores below 60 indicate a definite clinical case

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score Week 52	14.28 units on a scale Standard Deviation 12.814	—	—	—
Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score Week 104	17.85 units on a scale Standard Deviation 15.155	—	—	—
Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score Open label baseline	55.0 units on a scale Standard Deviation 11.96	—	—	—
Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score Week 28	10.94 units on a scale Standard Deviation 11.943	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050301

The Pediatric Q-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:

% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score), where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.

Outcome measures

Measure	Rollover From D1050301 n=271 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Open label baseline	57.14 percent of score Standard Deviation 14.850	—	—	—
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Week 28	7.48 percent of score Standard Deviation 13.336	—	—	—
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Week 52	9.98 percent of score Standard Deviation 13.541	—	—	—
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Week 104	11.74 percent of score Standard Deviation 15.783	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in ABC Irritability Subscale Score for subjects continued from study D1050325 The Aberrant Behavior Checklist (ABC) contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).

Irritability Subscale Score is calculated as summing of items 2, 4, 8, 10, 14, 19, 25, 29, 34, 36, 41, 47, 50, 52, and 57; as a result, ABC irritability subscale score ranges from 0 to 45.

In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score Open label baseline	19.0 units on a scale Standard Deviation 10.63	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score Week 52	-2.9 units on a scale Standard Deviation 9.85	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score Week 104	-4.2 units on a scale Standard Deviation 11.62	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score Week 28	-2.1 units on a scale Standard Deviation 9.16	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in ABC Lethargy and Social Withdrawal Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).

Lethargy and Social Withdrawal Subscale Score is calculated as summing of items 3, 5, 12, 16, 20, 23, 26, 30, 32, 37, 40, 42, 43, 53, 55, and 58. ABC Lethargy and Social Withdrawal Subscale Score ranges from 0 to 48.

In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score Open label baseline	10.3 score Standard Deviation 9.48	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score Week 28	-0.7 score Standard Deviation 7.01	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score Week 52	-1.1 score Standard Deviation 6.94	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score Week 104	-1.1 score Standard Deviation 6.57	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in ABC Stereotypic Behavior Subscale Score for subjects continued from study D1050325. The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Stereotypic behavior Subscale Score is calculated as summing of 6, 11, 17, 27, 35, 45, and 49 items . ABC Stereotypic behavior Subscale Score ranges from 0 to 21. Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). To score the ABC, the individual items for each subscale are simply summed to their respective totals. It is inappropriate to compute a "total aberrant score", based on a summation of all 58 items, as the subscales are largely independent. In general, higher values of ABC subscale scores represent greater severity

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score Open label baseline	6.1 score Standard Deviation 5.87	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score Week 28	-0.9 score Standard Deviation 3.55	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score Week 52	-0.9 score Standard Deviation 4.53	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score Week 104	-1.1 score Standard Deviation 4.41	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in ABC Hyperactivity and Noncompliance Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).

Hyperactivity and noncompliance Subscale Score is calculated as summing of 1, 7, 13, 15, 18, 21, 24, 28, 31, 38, 39, 44, 48, 51, 54, and 56 items. ABC hyperactivity and noncompliance Subscale Score ranges from 0 to 48.

In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score Open label baseline	24.1 score Standard Deviation 12.19	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score Week 28	-3.8 score Standard Deviation 10.16	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score Week 52	-4.3 score Standard Deviation 11.24	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score Week 104	-5.6 score Standard Deviation 12.84	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in ABC Inappropriate Speech Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).

Inappropriate speech Subscale Score is calculated as summing of 9, 22, 33, and 46 items. ABC inappropriate speech Subscale Score ranges from 0 to 12.

In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score Open label baseline	5.2 score Standard Deviation 3.61	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score Week 28	-0.7 score Standard Deviation 2.75	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score Week 52	-0.7 score Standard Deviation 2.88	—	—	—
Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score Week 104	-0.5 score Standard Deviation 3.00	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in Clinical Global Impression (CGI) - Severity Score for subjects continued from study D1050325 The CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1='Normal, not at all ill' to 7='Among the most extremely ill patients'. A higher score is associated with greater illness severity

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Clinical Global Impression (CGI) - Severity Score Week 104	-0.78 units on a scale Standard Deviation 1.313	—	—	—
Change From Baseline in Clinical Global Impression (CGI) - Severity Score Open label baseline	3.9 units on a scale Standard Deviation 1.25	—	—	—
Change From Baseline in Clinical Global Impression (CGI) - Severity Score Week 28	-0.43 units on a scale Standard Deviation 0.984	—	—	—
Change From Baseline in Clinical Global Impression (CGI) - Severity Score Week 52	-0.71 units on a scale Standard Deviation 1.078	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in CY-BOCS for subjects continued from study D1050325 CY-BOCS used in the study is a modification of the Yale-Brown Obsessive Compulsive Scale and contains total 7 items for compulsion. "Obsessions" section was removed as it is difficult to obtain valid information given typical language/cognitive delays in the population. Each item of the compulsive scale ranges from 0 to 4. At this time, item 1b ("compulsion-free interval") and item 6 ("peculiarity of the behavior") are not being used in the scoring. Item 7 is a rating for reliability, ranging from 0 (excellent) to 3 (poor). It reflects the interview's judgment regarding the confidence in the data collected hence it is not counted in the CY-BOCS total score. The CY-BOCS compulsion total score is the sums of item 1-5. As a result, the CY-BOCS compulsion total score may range from 0 to 20. In general, higher values of CY-BOCS scores represent greater severity of illness

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS) Open label baseline	10.2 units on a scale Standard Deviation 5.43	—	—	—
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS) Week 28	-2.2 units on a scale Standard Deviation 3.39	—	—	—
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS) Week 52	-2.3 units on a scale Standard Deviation 4.32	—	—	—
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS) Week 104	-3.2 units on a scale Standard Deviation 4.58	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Change from Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score for subjects continued from study D1050325 The CGSQ is comprised of total 21 items. Each item is rated on a 5-point Likert-type scale (1 (not at all a problem) to 5 (very much a problem)) and is grouped into three subscales: objective strain, subjective externalized strain, and subjective internalized strain. The 3 subscale scores are calculated as the averages of the corresponding individual items, which range in severity from 1 to 5.

Higher scores on each of these subscale scales indicate greater strain. A global strain score is calculated by summing the three subscales (i.e., objective strain, subjective externalized strain, and subjective internalized strain) to provide an indication of the total impact of the special demands on the family. Global strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain

Outcome measures

Measure	Rollover From D1050301 n=125 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score Open label baseline	7.95 score Standard Deviation 2.213	—	—	—
Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score Week 28	-0.48 score Standard Deviation 1.887	—	—	—
Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score Week 52	-0.60 score Standard Deviation 2.032	—	—	—
Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score Week 104	-0.63 score Standard Deviation 2.123	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050326

Change from Baseline in CDRS-R Total Score for subjects continued from study D1050326 CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 17 years. It contains 17 ordinally-scaled items that evaluate the presence and severity of symptoms commonly associated with depression in childhood. The CDRS-R is administered separately to the patient and to the caregiver; among 17 items, 14 items are based on separate interviews with child and parent, 3 items are based solely on the rater's observation of child (ie, no questions).The 14 items are rated on a 1 (no psychopathology) to 7 (most psychopathology) scale, where a rating of 3 represents mild psychopathology. The 3 items (sleep disturbance, appetite disturbance, listless speech) are rated on a 1 (no pathology) to 5 (most pathology) scale. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness

Outcome measures

Measure	Rollover From D1050301 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score Week 104	-16.4 units on a scale Standard Deviation 13.24	—	—	—
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score Week 52	-13.4 units on a scale Standard Deviation 13.01	—	—	—
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score Open label baseline	39.2 units on a scale Standard Deviation 13.38	—	—	—
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score Week 28	-9.9 units on a scale Standard Deviation 13.48	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050326

Change from Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score for subjects continued from study D1050326 The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity.

Outcome measures

Measure	Rollover From D1050301 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score Open label baseline	3.2 units on a scale Standard Deviation 1.09	—	—	—
Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score Week 28	-1.10 units on a scale Standard Deviation 1.140	—	—	—
Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score Week 52	-1.36 units on a scale Standard Deviation 1.184	—	—	—
Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score Week 104	-1.61 units on a scale Standard Deviation 1.153	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050326

Change from Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score for subjects continued from study D1050326 The Children's Global Assessment Scale (CGAS) is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children under the age of 18, where 1 represents the most impaired functioning and 100, superior functioning. Each decile (e.g., 1-10, 11-20) has a descriptive header (e.g., "Moderate impairment in functioning in most domains") and examples of behaviors and types of environmental accommodations that might be seen at that level of functioning. Scores above 70 on the CGAS indicate functioning within the range of typically developing children of the same age as the child being rated while scores below 60 indicate a definite clinical case

Outcome measures

Measure	Rollover From D1050301 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score Open label baseline	61.1 units on a scale Standard Deviation 12.54	—	—	—
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score Week 28	11.17 units on a scale Standard Deviation 13.893	—	—	—
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score Week 52	14.67 units on a scale Standard Deviation 14.347	—	—	—
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score Week 104	18.96 units on a scale Standard Deviation 14.898	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050326

Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050326

The Pediatric Q-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:

% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score), where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.

Outcome measures

Measure	Rollover From D1050301 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Week 28	8.16 score Standard Deviation 16.345	—	—	—
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Week 104	14.75 score Standard Deviation 16.744	—	—	—
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Open label baseline	59.52 score Standard Deviation 15.569	—	—	—
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score Week 52	11.37 score Standard Deviation 16.343	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: for subjects continued from study D1050326

Change from Baseline in PAR Total Score for subjects continued from study D1050326 The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6 17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. Scores of 8 or 9 are not counted in the summation as per the PARS instructions. The PARS total score over all 7 questions ranges in value from 0 to 35.A higher PARS total score

Outcome measures

Measure	Rollover From D1050301 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score Open label baseline	8.0 units on a scale Standard Deviation 6.94	—	—	—
Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score Week 52	-3.2 units on a scale Standard Deviation 5.97	—	—	—
Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score Week 104	-4.9 units on a scale Standard Deviation 6.41	—	—	—
Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score Week 28	-2.7 units on a scale Standard Deviation 5.41	—	—	—

SECONDARY outcome

Timeframe: Open-Label Baseline, Week 28, Week 52, and Week 104

Population: subjects continued from study D1050326

Change from Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score for subjects continued from study D1050326 The ADHD-RS IV is a validated scale that measures the behaviors of children with ADHD. The ADHD-RS IV consists of 18 items reflecting current symptomatology of ADHD based on DSM-IV-TR criteria. Each item is scored from a range of 0 (no symptoms) to 3 (severe symptoms) with total scores ranging from 0 to 54. The 18 items may be grouped into two sub-scales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17), ranging from 0 to 27. A higher ADHD-RS total score and sub-scales scores are associated with greater illness severity

Outcome measures

Measure	Rollover From D1050301 n=305 Participants Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Lurasidone (All Indications) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score Open label baseline	9.4 units on a scale Standard Deviation 10.58	—	—	—
Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score Week 28	-2.2 units on a scale Standard Deviation 6.29	—	—	—
Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score Week 52	-2.4 units on a scale Standard Deviation 5.83	—	—	—
Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score Week 104	-3.3 units on a scale Standard Deviation 6.24	—	—	—

Adverse Events

Rollover From D1050301

Serious events: 28 serious events

Other events: 184 other events

Deaths: 0 deaths

Rollover From D1050325

Serious events: 13 serious events

Other events: 94 other events

Deaths: 0 deaths

Rollover From D1050326

Serious events: 37 serious events

Other events: 198 other events

Deaths: 0 deaths

Total D1050302

Serious events: 78 serious events

Other events: 560 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rollover From D1050301 n=271 participants at risk Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 n=125 participants at risk Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 n=305 participants at risk Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Total D1050302 n=701 participants at risk total from study
Injury, poisoning and procedural complications Intentional overdose	0.74% 2/271 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.43% 3/701 • Number of events 3 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.29% 2/701 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Soft tissue injury	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Concussion	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Contusion	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Foot fracture	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Fractured coccyx	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Frostbite	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Peripheral nerve injury	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Suicidal ideation	3.0% 8/271 • Number of events 10 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.6% 5/305 • Number of events 5 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	2.0% 14/701 • Number of events 16 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Schizophrenia	4.1% 11/271 • Number of events 12 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.6% 11/701 • Number of events 12 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Suicide attempt	0.37% 1/271 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	2.0% 6/305 • Number of events 6 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.1% 8/701 • Number of events 9 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Bipolar I disorder	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	2.0% 6/305 • Number of events 6 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.86% 6/701 • Number of events 6 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Psychotic disorder	1.8% 5/271 • Number of events 5 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.71% 5/701 • Number of events 5 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Aggression	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	2.4% 3/125 • Number of events 3 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.57% 4/701 • Number of events 4 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Bipolar disorder	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.3% 4/305 • Number of events 4 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.57% 4/701 • Number of events 4 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Depression	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.98% 3/305 • Number of events 3 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.57% 4/701 • Number of events 4 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Suicidal behaviour	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.29% 2/701 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Abnormal behaviour	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Agitation	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Confusional state	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Depressive symptom	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Emotional disorder	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders intentional drug misuse	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Violence-related symptom	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Hand fracture	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.66% 2/305 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.43% 3/701 • Number of events 3 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Infections and infestations Appendicitis	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.66% 2/305 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.43% 3/701 • Number of events 3 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Infections and infestations Osteomyelitis	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Nervous system disorders Convulsion	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.29% 2/701 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Nervous system disorders Akathisia	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Nervous system disorders Ataxia	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Gastrointestinal disorders Abdominal pain	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Gastrointestinal disorders Bezoar	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Renal and urinary disorders Haematinuria	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Renal and urinary disorders Nephrolithiasis	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
General disorders Pyrexia	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.80% 1/125 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/271 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.14% 1/701 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)

Other adverse events

Measure	Rollover From D1050301 n=271 participants at risk Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)	Rollover From D1050325 n=125 participants at risk Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)	Rollover From D1050326 n=305 participants at risk Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)	Total D1050302 n=701 participants at risk total from study
Nervous system disorders Headache	24.0% 65/271 • Number of events 126 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	14.4% 18/125 • Number of events 31 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	23.9% 73/305 • Number of events 124 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	22.3% 156/701 • Number of events 281 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Nervous system disorders Somnolence	8.9% 24/271 • Number of events 26 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	11.2% 14/125 • Number of events 17 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	9.8% 30/305 • Number of events 30 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	9.7% 68/701 • Number of events 73 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Nervous system disorders Akathisia	8.1% 22/271 • Number of events 33 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	6.4% 8/125 • Number of events 12 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	6.2% 19/305 • Number of events 27 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	7.0% 49/701 • Number of events 72 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Infections and infestations Nasopharyngitis	8.9% 24/271 • Number of events 30 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	22.4% 28/125 • Number of events 42 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	8.5% 26/305 • Number of events 34 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	11.1% 78/701 • Number of events 106 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Infections and infestations Upper respiratory tract infection	3.7% 10/271 • Number of events 10 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	11.2% 14/125 • Number of events 18 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.9% 12/305 • Number of events 15 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.1% 36/701 • Number of events 43 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Anxiety	12.9% 35/271 • Number of events 53 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	11.2% 14/125 • Number of events 23 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	8.5% 26/305 • Number of events 35 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	10.7% 75/701 • Number of events 111 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Insomnia	8.5% 23/271 • Number of events 32 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	10.4% 13/125 • Number of events 18 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	7.2% 22/305 • Number of events 26 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	8.3% 58/701 • Number of events 76 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Agitation	7.4% 20/271 • Number of events 30 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	11.2% 14/125 • Number of events 24 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.6% 11/305 • Number of events 15 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	6.4% 45/701 • Number of events 69 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Depression	6.6% 18/271 • Number of events 23 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.6% 7/125 • Number of events 8 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	4.3% 13/305 • Number of events 15 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.4% 38/701 • Number of events 46 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Gastrointestinal disorders Nausea	12.5% 34/271 • Number of events 59 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	7.2% 9/125 • Number of events 16 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	16.4% 50/305 • Number of events 81 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	13.3% 93/701 • Number of events 156 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Gastrointestinal disorders Vomiting	5.9% 16/271 • Number of events 21 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	21.6% 27/125 • Number of events 41 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	8.2% 25/305 • Number of events 46 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	9.7% 68/701 • Number of events 108 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Gastrointestinal disorders Diarrhoea	4.8% 13/271 • Number of events 17 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.6% 7/125 • Number of events 8 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.9% 18/305 • Number of events 24 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.4% 38/701 • Number of events 49 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Investigations Weight increased	7.7% 21/271 • Number of events 22 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	16.0% 20/125 • Number of events 21 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	9.5% 29/305 • Number of events 30 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	10.0% 70/701 • Number of events 73 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
General disorders Irritability	4.4% 12/271 • Number of events 15 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	9.6% 12/125 • Number of events 17 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.9% 12/305 • Number of events 16 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.1% 36/701 • Number of events 48 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Respiratory, thoracic and mediastinal disorders Cough	4.1% 11/271 • Number of events 12 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	11.2% 14/125 • Number of events 16 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	4.6% 14/305 • Number of events 16 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.6% 39/701 • Number of events 44 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Nervous system disorders Dizziness	6.3% 17/271 • Number of events 23 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.6% 2/125 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	4.6% 14/305 • Number of events 22 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	4.7% 33/701 • Number of events 47 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Schizophrenia	8.9% 24/271 • Number of events 42 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/305 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.4% 24/701 • Number of events 42 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Infections and infestations Viral infection	6.3% 17/271 • Number of events 33 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.6% 2/125 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.9% 12/305 • Number of events 30 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	4.4% 31/701 • Number of events 65 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Gastrointestinal disorders Toothache	7.0% 19/271 • Number of events 26 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.6% 2/125 • Number of events 3 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	2.0% 6/305 • Number of events 8 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.9% 27/701 • Number of events 37 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Gastrointestinal disorders Constipation	5.2% 14/271 • Number of events 18 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.2% 4/125 • Number of events 6 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	2.3% 7/305 • Number of events 8 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.6% 25/701 • Number of events 32 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Infections and infestations Pharyngitis streptococcal	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	6.4% 8/125 • Number of events 8 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.66% 2/305 • Number of events 2 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.6% 11/701 • Number of events 11 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
General disorders Fatigue	1.8% 5/271 • Number of events 5 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	8.0% 10/125 • Number of events 14 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.9% 18/305 • Number of events 20 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	4.7% 33/701 • Number of events 39 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
General disorders Pyrexia	2.6% 7/271 • Number of events 12 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.6% 7/125 • Number of events 9 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.3% 10/305 • Number of events 13 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	3.4% 24/701 • Number of events 34 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Immune system disorders Seasonal allergy	1.5% 4/271 • Number of events 4 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	6.4% 8/125 • Number of events 9 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.6% 5/305 • Number of events 5 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	2.4% 17/701 • Number of events 18 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Infections and infestations Rhinitis	4.1% 11/271 • Number of events 15 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.00% 0/125 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	6.2% 19/305 • Number of events 24 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	4.3% 30/701 • Number of events 39 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Psychiatric disorders Aggression	0.37% 1/271 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	5.6% 7/125 • Number of events 8 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	0.33% 1/305 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)	1.3% 9/701 • Number of events 10 • An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)

Additional Information

CNS Medical Director

Sunovion Pharmaceuticals Inc.

Phone: 866-503-6351

Email: ClinicalTrialDisclosure@sunovion.com

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