Pediatric Open-Label Extension Study

Sponsor
Sunovion (Industry)
Overall Status
Completed
CT.gov ID
NCT01914393
Collaborator
(none)
702
88
1
60.6
8
0.1

Study Details

Study Description

Brief Summary

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

Condition or Disease Intervention/Treatment Phase
  • Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
702 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects
Actual Study Start Date :
Sep 30, 2013
Actual Primary Completion Date :
Oct 17, 2018
Actual Study Completion Date :
Oct 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lurasidone 20, 40, 60, 80 mg, flexibly dosed

Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily

Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed
Other Names:
  • Latuda
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) [During 104 Weeks (2-years) treatment period]

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

    Secondary Outcome Measures

    1. Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score [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.

    2. Change From Baseline in PANSS Positive Subscale Score [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

    3. Change From Baseline in PANSS Negative Subscale Score [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.

    4. Change From Baseline in PANSS General Psychopathology Subscale Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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.

    5. Change From Baseline in PANSS Excitability Subscale Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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.

    6. Change From Baseline in the Clinical Global Impression -Severity Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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

    7. Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score [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

    8. Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score [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.

    9. Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score [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

    10. Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score [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

    11. Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score [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

    12. Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score [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

    13. Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score [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

    14. Change From Baseline in Clinical Global Impression (CGI) - Severity Score [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

    15. Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS) [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

    16. Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score [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

    17. Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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

    18. Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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.

    19. Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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

    20. Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score [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 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.

    21. Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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

    22. Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score [Open-Label Baseline, Week 28, Week 52, and Week 104]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.

    • Subject has completed Study D1050301 (Visit 9) OR

    • Subject has completed Study D1050325 (Visit 9) OR

    • Subject has completed Study D1050326 (Visit 8)

    • Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol.

    • A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study

    • Females who participate in this study:

    • are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-

    • practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR-

    • are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

    • Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

    Exclusion Criteria:
    • Subject is considered by the investigator to be at imminent risk of suicide.

    • Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Harmonex Neuroscience Research Dothan Alabama United States 36303
    2 Diligent Clinical Trials, Inc Downey California United States 90241
    3 University of California San Francisco Medical Center San Francisco California United States 94143
    4 Neuropsychiatric Research Center of Orange County Santa Ana California United States 92701
    5 Sarkis Clinical Trials - Parent Gainesville Florida United States 32607
    6 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
    7 APG Research, LLC Orlando Florida United States 32803
    8 University of South Florida Saint Petersburg Florida United States 33701
    9 Medical Research Group of Central Florida Sanford Florida United States 32771
    10 University of South Florida Rothman Center of Neuropychiatry Tampa Florida United States 33613
    11 Atlanta Center for Medical Research Atlanta Georgia United States 30308
    12 Attalla Consultants, LLC Smyrna Georgia United States 30080
    13 Psychiatric Associates Overland Park Kansas United States 66211
    14 University Of Kentucky Lexington Kentucky United States 40509
    15 Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 Lake Charles Louisiana United States 70601
    16 Kennedy Krieger Institute Baltimore Maryland United States 21205
    17 Neurobehavioral medicine Group, LLC Bloomfield Hills Michigan United States 48302
    18 St. Charles Psychiatric Associates Saint Charles Missouri United States 63301
    19 Jersey Shore University Medical Center Neptune New Jersey United States 07753
    20 North Shore/Long Island Jewish PRIME Glen Oaks New York United States 11004
    21 Dr. Jeanette Cueva Mount Kisco New York United States 10549
    22 Montefiore Medical Center PRIME New York New York United States 10467
    23 Finger Lakes Clinical Research Rochester New York United States 10618
    24 Richmond Behavioral Associates Staten Island New York United States 10312
    25 University of Cincinnati Medical Center Cincinnati Ohio United States 45219
    26 University Hospitals Case Medical Center Cleveland Ohio United States 44106
    27 The Ohio State University Nisonger Center Columbus Ohio United States 43210
    28 Cutting Edge Research Group Oklahoma City Oklahoma United States 73116
    29 Pillar Clinical Research, LLC Dallas Texas United States 75243
    30 Family Psychiatry of The Woodlands, P.A. The Woodlands Texas United States 77381
    31 Ericksen Research & Development, LLC Clinton Utah United States 84015
    32 University of Virginia Charlottesville Virginia United States 22903
    33 Neuroscience, Inc. Herndon Virginia United States 20170
    34 Clinical Research Partners, LLC Petersburg Virginia United States 23805
    35 Carilion Clinic Roanoke Virginia United States 24014
    36 MHC - Ruse, EOOD Ruse Bulgaria 7003
    37 UMHAT "Alexandrovska" EAD Sofia Bulgaria 1431
    38 MHAT-Targovishte, AD Targovishte Bulgaria 7700
    39 DCC "Mladost M" - Varna, OOD Varna Bulgaria 9020
    40 Centro de Investigaciones y Proyectos en Neurociencias CIPNA Barranquilla Colombia
    41 E.S.E. Hospital Mental de Antioquia Bello Colombia 0000
    42 Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda Bogota Colombia 00000
    43 CHU Nantes - Hôpital Mère-Enfant Nantes Cedex 1 France 44093
    44 Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert Budapest Hungary 1021
    45 Bekes Megyei Pandy Kalman Korhaz Gyula Hungary 57--
    46 Seoul National University Hospital Seoul Gyeonggi-do Korea, Republic of 110774
    47 Chonnam National University Hospital Gwangju Korea, Republic of 501-757
    48 Inha University Hospital Incheon Korea, Republic of 400-711
    49 Chonbuk National University Hospital Jeonju Korea, Republic of 561-712
    50 University Malaya Medical Centre Kuala Lumpur Malaysia 59100
    51 Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. Culiacan Sinaloa Mexico 80020
    52 Dr. Jessica Rosas Escobar Durango Mexico 34000
    53 Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Durango Mexico 34000
    54 Accelerium S. de R.L. de C.V. Monterrey Mexico 64000
    55 Instituto de Informacion de Investigacion en Salud Mental Monterrey Mexico 64710
    56 Av Modesto Arreola #917 Ote. Col Centro Nuevo León Mexico 64000
    57 Alexian Brothers Health and Wellness Center Davao City Philippines 8000
    58 West Visayas State University Medical Center Iloilo Philippines 5000
    59 National Center for Mental Health Mandaluyong City Philippines 1553
    60 Veterans Memorial Medical Center Quezon City Philippines 1101
    61 NZOZ Poradnia Zdrowia Psychicznego Kobierzyce Poland 55-040
    62 Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy Toruń Poland 87-100
    63 Centro de Investigacion Clinica Psiquiatrica Caguas Puerto Rico 00725
    64 Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia Bucuresti Romania 041914
    65 Spitalul Clinic de Psihiatrie Socola Iasi Romania 700282
    66 Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara Timisoara Romania 300239
    67 Sverdiovsk Regional Clinical Psychiatric Hospital Ekaterinburg Russian Federation 62003
    68 GUZ Lipetsk Regional psychoneurological Hospital #1 Lipetsk Russian Federation 399313
    69 Closed corporation "Scientific Center of Personalized Psychiatry" Moscow Russian Federation 119180
    70 Scientific Center of Personalized Psychiatry Moscow Russian Federation 119180
    71 State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod" Nizhny Novgorod Russian Federation 603155
    72 SHI "City Psychoneurological dispensary #7 (with Hospital)" Saint Petersburg Russian Federation 190005
    73 Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin Saint Petersburg Russian Federation 197022
    74 Bekhterev Institute Saint Petersburg Russian Federation
    75 Regional Clinical Mental Hospital of Saint Sofiya Saratow Russian Federation 410060
    76 FSBSI "Scientific Research Institute of Mental Health" Tomsk Russian Federation 634014
    77 State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital" Yaroslavl Russian Federation 150003
    78 Hospital Marítimo de Torremolinos Torremolinos Málaga Spain 29620
    79 RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU Ivano Frankivsk Ukraine 76014
    80 SI Institute of Neurology, Psychiatry and Narcology of NAMSU Kharkiv Ukraine 61068
    81 SI Institute of Children and Adolescents Healthcare of NAMSU Kharkiv Ukraine 61153
    82 TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions Kyiv Ukraine 04080
    83 CI Lviv Regional Clinical Psychiatric Hospital Lviv Ukraine 79021
    84 Odesa Regional Psychoneurological Dispensary, Outpatient Dept. Odesa Ukraine 65014
    85 O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy Poltava Ukraine 36006
    86 CI Kherson Regional Psychiatric Hospital of Kherson RC Stepanivka Ukraine 73488
    87 Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU Ternopil Ukraine 46020
    88 Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI Vinnitsia Ukraine 21018

    Sponsors and Collaborators

    • Sunovion

    Investigators

    • Study Director: Lurasidone Medical Director, MD, Sunovion

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT01914393
    Other Study ID Numbers:
    • D1050302
    • 2013-001694-24
    First Posted:
    Aug 2, 2013
    Last Update Posted:
    Dec 19, 2019
    Last Verified:
    Dec 1, 2019
    Keywords provided by Sunovion
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details participation in the preceding double-blind efficacy and safety studies (D1050301, NCT01911429,; D1050325, NCT01911442; or D1050326, NCT02046369) were eligible for enrollment in this study.
    Pre-assignment Detail 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
    Arm/Group Title Rollover From D1050301 Rollover From D1050325 Rollover From D1050326
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
    Period Title: Overall Study
    STARTED 271 125 306
    COMPLETED 156 54 168
    NOT COMPLETED 115 71 138

    Baseline Characteristics

    Arm/Group Title Rollover From D1050301 Rollover From D1050325 Rollover From D1050326 Total
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression) Total of all reporting groups
    Overall Participants 271 125 305 701
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    15.5
    (1.44)
    11.1
    (3.12)
    14.4
    (2.18)
    14.3
    (2.66)
    Age, Customized (participants) [Number]
    Children (2-11 years)
    0
    0%
    75
    60%
    36
    11.8%
    111
    15.8%
    Adolescents (12-17 years)
    257
    94.8%
    50
    40%
    258
    84.6%
    565
    80.6%
    Adults (18-64 years)
    14
    5.2%
    0
    0%
    11
    3.6%
    25
    3.6%
    Sex: Female, Male (Count of Participants)
    Female
    101
    37.3%
    23
    18.4%
    152
    49.8%
    276
    39.4%
    Male
    170
    62.7%
    102
    81.6%
    153
    50.2%
    425
    60.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    36
    13.3%
    21
    16.8%
    54
    17.7%
    111
    15.8%
    Not Hispanic or Latino
    235
    86.7%
    104
    83.2%
    251
    82.3%
    590
    84.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    2
    1.6%
    2
    0.7%
    4
    0.6%
    Asian
    11
    4.1%
    2
    1.6%
    10
    3.3%
    23
    3.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    38
    14%
    21
    16.8%
    26
    8.5%
    85
    12.1%
    White
    197
    72.7%
    96
    76.8%
    235
    77%
    528
    75.3%
    More than one race
    25
    9.2%
    4
    3.2%
    32
    10.5%
    61
    8.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    North America
    82
    30.3%
    125
    100%
    125
    41%
    332
    47.4%
    South America
    21
    7.7%
    0
    0%
    40
    13.1%
    61
    8.7%
    Europe
    157
    57.9%
    0
    0%
    131
    43%
    288
    41.1%
    Asia
    11
    4.1%
    0
    0%
    9
    3%
    20
    2.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)
    Description The Safety population consists of all subjects who received at least one dose of study drug in this study.
    Time Frame During 104 Weeks (2-years) treatment period

    Outcome Measure Data

    Analysis Population Description
    The Safety population consists of all subjects who received at least one dose of study drug in this study.
    Arm/Group Title Rollover From D1050301 Rollover From D1050325 Rollover From D1050326 Lurasidone (All Indications)
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression) L Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for all indications
    Measure Participants 271 125 305 701
    Subjects with at least one treatment emergent AE
    214
    79%
    106
    84.8%
    252
    82.6%
    572
    81.6%
    Subjects with at least one treatment emergent SAE
    28
    10.3%
    13
    10.4%
    37
    12.1%
    78
    11.1%
    Subjects with AE Leading to Discontinuation
    28
    10.3%
    18
    14.4%
    31
    10.2%
    77
    11%
    2. Secondary Outcome
    Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
    Description 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.
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open Label Baseline
    76.0
    (17.72)
    Week 28
    -11.9
    (13.74)
    Week 52
    -15.6
    (14.97)
    Week 104
    -18.4
    (16.73)
    3. Secondary Outcome
    Title Change From Baseline in PANSS Positive Subscale Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open Label baseline
    17.9
    (5.51)
    Week 28
    -3.9
    (4.68)
    Week 52
    -5.1
    (5.13)
    Week 104
    -5.4
    (5.66)
    4. Secondary Outcome
    Title Change From Baseline in PANSS Negative Subscale Score
    Description 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.
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open Label baseline
    20.5
    (4.91)
    Week 28
    -2.6
    (4.16)
    Week 52
    -3.4
    (4.34)
    Week 104
    -4.3
    (4.77)
    5. Secondary Outcome
    Title Change From Baseline in PANSS General Psychopathology Subscale Score
    Description 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.
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050301
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open label baseline
    37.5
    (9.38)
    Week 28
    -5.4
    (7.28)
    Week 52
    -7.2
    (7.65)
    Week 104
    -8.7
    (8.68)
    6. Secondary Outcome
    Title Change From Baseline in PANSS Excitability Subscale Score
    Description 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.
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050301
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open label baseline
    9.0
    (3.73)
    Week 28
    -1.3
    (3.09)
    Week 52
    -1.7
    (3.31)
    week 104
    -2.1
    (3.63)
    7. Secondary Outcome
    Title Change From Baseline in the Clinical Global Impression -Severity Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050301
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open label baseline
    4.0
    (0.97)
    Week 28
    -0.87
    (0.941)
    Week 52
    -1.10
    (1.084)
    Week 104
    -1.31
    (1.196)
    8. Secondary Outcome
    Title Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open label baseline
    55.0
    (11.96)
    Week 28
    10.94
    (11.943)
    Week 52
    14.28
    (12.814)
    Week 104
    17.85
    (15.155)
    9. Secondary Outcome
    Title Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
    Description 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.
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050301
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia)
    Measure Participants 271
    Open label baseline
    57.14
    (14.850)
    Week 28
    7.48
    (13.336)
    Week 52
    9.98
    (13.541)
    Week 104
    11.74
    (15.783)
    10. Secondary Outcome
    Title Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    19.0
    (10.63)
    Week 28
    -2.1
    (9.16)
    Week 52
    -2.9
    (9.85)
    Week 104
    -4.2
    (11.62)
    11. Secondary Outcome
    Title Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    10.3
    (9.48)
    Week 28
    -0.7
    (7.01)
    Week 52
    -1.1
    (6.94)
    Week 104
    -1.1
    (6.57)
    12. Secondary Outcome
    Title Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    6.1
    (5.87)
    Week 28
    -0.9
    (3.55)
    Week 52
    -0.9
    (4.53)
    Week 104
    -1.1
    (4.41)
    13. Secondary Outcome
    Title Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    24.1
    (12.19)
    Week 28
    -3.8
    (10.16)
    Week 52
    -4.3
    (11.24)
    Week 104
    -5.6
    (12.84)
    14. Secondary Outcome
    Title Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    5.2
    (3.61)
    Week 28
    -0.7
    (2.75)
    Week 52
    -0.7
    (2.88)
    Week 104
    -0.5
    (3.00)
    15. Secondary Outcome
    Title Change From Baseline in Clinical Global Impression (CGI) - Severity Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    3.9
    (1.25)
    Week 28
    -0.43
    (0.984)
    Week 52
    -0.71
    (1.078)
    Week 104
    -0.78
    (1.313)
    16. Secondary Outcome
    Title Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    10.2
    (5.43)
    Week 28
    -2.2
    (3.39)
    Week 52
    -2.3
    (4.32)
    Week 104
    -3.2
    (4.58)
    17. Secondary Outcome
    Title Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Rollover From D1050325
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder)
    Measure Participants 125
    Open label baseline
    7.95
    (2.213)
    Week 28
    -0.48
    (1.887)
    Week 52
    -0.60
    (2.032)
    Week 104
    -0.63
    (2.123)
    18. Secondary Outcome
    Title Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050326
    Arm/Group Title Rollover From D1050326
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
    Measure Participants 305
    Open label baseline
    39.2
    (13.38)
    Week 28
    -9.9
    (13.48)
    Week 52
    -13.4
    (13.01)
    Week 104
    -16.4
    (13.24)
    19. Secondary Outcome
    Title Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score
    Description 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.
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050326
    Arm/Group Title Rollover From D1050326
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
    Measure Participants 305
    Open label baseline
    3.2
    (1.09)
    Week 28
    -1.10
    (1.140)
    Week 52
    -1.36
    (1.184)
    Week 104
    -1.61
    (1.153)
    20. Secondary Outcome
    Title Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050326
    Arm/Group Title Rollover From D1050326
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
    Measure Participants 305
    Open label baseline
    61.1
    (12.54)
    Week 28
    11.17
    (13.893)
    Week 52
    14.67
    (14.347)
    Week 104
    18.96
    (14.898)
    21. Secondary Outcome
    Title Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
    Description 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.
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050326
    Arm/Group Title Rollover From D1050326
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
    Measure Participants 305
    Open label baseline
    59.52
    (15.569)
    Week 28
    8.16
    (16.345)
    Week 52
    11.37
    (16.343)
    Week 104
    14.75
    (16.744)
    22. Secondary Outcome
    Title Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    for subjects continued from study D1050326
    Arm/Group Title Rollover From D1050326
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
    Measure Participants 305
    Open label baseline
    8.0
    (6.94)
    Week 28
    -2.7
    (5.41)
    Week 52
    -3.2
    (5.97)
    Week 104
    -4.9
    (6.41)
    23. Secondary Outcome
    Title Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score
    Description 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
    Time Frame Open-Label Baseline, Week 28, Week 52, and Week 104

    Outcome Measure Data

    Analysis Population Description
    subjects continued from study D1050326
    Arm/Group Title Rollover From D1050326
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression)
    Measure Participants 305
    Open label baseline
    9.4
    (10.58)
    Week 28
    -2.2
    (6.29)
    Week 52
    -2.4
    (5.83)
    Week 104
    -3.3
    (6.24)

    Adverse Events

    Time Frame An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
    Adverse Event Reporting Description
    Arm/Group Title Rollover From D1050301 Rollover From D1050325 Rollover From D1050326 Total D1050302
    Arm/Group Description Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301(schizophrenia) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (autistic disorder) Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (bi-polar depression) total from study
    All Cause Mortality
    Rollover From D1050301 Rollover From D1050325 Rollover From D1050326 Total D1050302
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/271 (0%) 0/125 (0%) 0/305 (0%) 0/701 (0%)
    Serious Adverse Events
    Rollover From D1050301 Rollover From D1050325 Rollover From D1050326 Total D1050302
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 28/271 (10.3%) 13/125 (10.4%) 37/305 (12.1%) 78/701 (11.1%)
    Gastrointestinal disorders
    Abdominal pain 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Bezoar 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    General disorders
    Pyrexia 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Infections and infestations
    Appendicitis 1/271 (0.4%) 1 0/125 (0%) 0 2/305 (0.7%) 2 3/701 (0.4%) 3
    Osteomyelitis 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Injury, poisoning and procedural complications
    Hand fracture 0/271 (0%) 0 1/125 (0.8%) 1 2/305 (0.7%) 2 3/701 (0.4%) 3
    Intentional overdose 2/271 (0.7%) 2 0/125 (0%) 0 1/305 (0.3%) 1 3/701 (0.4%) 3
    Wrist fracture 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 2/701 (0.3%) 2
    Accidental overdose 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Ankle fracture 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 1/701 (0.1%) 1
    Clavicle fracture 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Concussion 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Contusion 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Foot fracture 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Fractured coccyx 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 1/701 (0.1%) 1
    Frostbite 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Peripheral nerve injury 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 1/701 (0.1%) 1
    Soft tissue injury 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Tibia fracture 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 1/701 (0.1%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Nervous system disorders
    Convulsion 0/271 (0%) 0 1/125 (0.8%) 1 1/305 (0.3%) 1 2/701 (0.3%) 2
    Akathisia 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 1/701 (0.1%) 1
    Ataxia 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 1/701 (0.1%) 1
    Psychiatric disorders
    Suicidal ideation 8/271 (3%) 10 1/125 (0.8%) 1 5/305 (1.6%) 5 14/701 (2%) 16
    Schizophrenia 11/271 (4.1%) 12 0/125 (0%) 0 0/305 (0%) 0 11/701 (1.6%) 12
    Suicide attempt 1/271 (0.4%) 2 1/125 (0.8%) 1 6/305 (2%) 6 8/701 (1.1%) 9
    Bipolar I disorder 0/271 (0%) 0 0/125 (0%) 0 6/305 (2%) 6 6/701 (0.9%) 6
    Psychotic disorder 5/271 (1.8%) 5 0/125 (0%) 0 0/305 (0%) 0 5/701 (0.7%) 5
    Aggression 1/271 (0.4%) 1 3/125 (2.4%) 3 0/305 (0%) 0 4/701 (0.6%) 4
    Bipolar disorder 0/271 (0%) 0 0/125 (0%) 0 4/305 (1.3%) 4 4/701 (0.6%) 4
    Depression 1/271 (0.4%) 1 0/125 (0%) 0 3/305 (1%) 3 4/701 (0.6%) 4
    Suicidal behaviour 1/271 (0.4%) 1 0/125 (0%) 0 1/305 (0.3%) 1 2/701 (0.3%) 2
    Abnormal behaviour 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Agitation 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Confusional state 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Depressive symptom 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Emotional disorder 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    intentional drug misuse 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Violence-related symptom 0/271 (0%) 0 1/125 (0.8%) 1 0/305 (0%) 0 1/701 (0.1%) 1
    Renal and urinary disorders
    Haematinuria 1/271 (0.4%) 1 0/125 (0%) 0 0/305 (0%) 0 1/701 (0.1%) 1
    Nephrolithiasis 0/271 (0%) 0 0/125 (0%) 0 1/305 (0.3%) 1 1/701 (0.1%) 1
    Other (Not Including Serious) Adverse Events
    Rollover From D1050301 Rollover From D1050325 Rollover From D1050326 Total D1050302
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 184/271 (67.9%) 94/125 (75.2%) 198/305 (64.9%) 560/701 (79.9%)
    Gastrointestinal disorders
    Nausea 34/271 (12.5%) 59 9/125 (7.2%) 16 50/305 (16.4%) 81 93/701 (13.3%) 156
    Vomiting 16/271 (5.9%) 21 27/125 (21.6%) 41 25/305 (8.2%) 46 68/701 (9.7%) 108
    Diarrhoea 13/271 (4.8%) 17 7/125 (5.6%) 8 18/305 (5.9%) 24 38/701 (5.4%) 49
    Toothache 19/271 (7%) 26 2/125 (1.6%) 3 6/305 (2%) 8 27/701 (3.9%) 37
    Constipation 14/271 (5.2%) 18 4/125 (3.2%) 6 7/305 (2.3%) 8 25/701 (3.6%) 32
    General disorders
    Irritability 12/271 (4.4%) 15 12/125 (9.6%) 17 12/305 (3.9%) 16 36/701 (5.1%) 48
    Fatigue 5/271 (1.8%) 5 10/125 (8%) 14 18/305 (5.9%) 20 33/701 (4.7%) 39
    Pyrexia 7/271 (2.6%) 12 7/125 (5.6%) 9 10/305 (3.3%) 13 24/701 (3.4%) 34
    Immune system disorders
    Seasonal allergy 4/271 (1.5%) 4 8/125 (6.4%) 9 5/305 (1.6%) 5 17/701 (2.4%) 18
    Infections and infestations
    Nasopharyngitis 24/271 (8.9%) 30 28/125 (22.4%) 42 26/305 (8.5%) 34 78/701 (11.1%) 106
    Upper respiratory tract infection 10/271 (3.7%) 10 14/125 (11.2%) 18 12/305 (3.9%) 15 36/701 (5.1%) 43
    Viral infection 17/271 (6.3%) 33 2/125 (1.6%) 2 12/305 (3.9%) 30 31/701 (4.4%) 65
    Pharyngitis streptococcal 1/271 (0.4%) 1 8/125 (6.4%) 8 2/305 (0.7%) 2 11/701 (1.6%) 11
    Rhinitis 11/271 (4.1%) 15 0/125 (0%) 0 19/305 (6.2%) 24 30/701 (4.3%) 39
    Investigations
    Weight increased 21/271 (7.7%) 22 20/125 (16%) 21 29/305 (9.5%) 30 70/701 (10%) 73
    Nervous system disorders
    Headache 65/271 (24%) 126 18/125 (14.4%) 31 73/305 (23.9%) 124 156/701 (22.3%) 281
    Somnolence 24/271 (8.9%) 26 14/125 (11.2%) 17 30/305 (9.8%) 30 68/701 (9.7%) 73
    Akathisia 22/271 (8.1%) 33 8/125 (6.4%) 12 19/305 (6.2%) 27 49/701 (7%) 72
    Dizziness 17/271 (6.3%) 23 2/125 (1.6%) 2 14/305 (4.6%) 22 33/701 (4.7%) 47
    Psychiatric disorders
    Anxiety 35/271 (12.9%) 53 14/125 (11.2%) 23 26/305 (8.5%) 35 75/701 (10.7%) 111
    Insomnia 23/271 (8.5%) 32 13/125 (10.4%) 18 22/305 (7.2%) 26 58/701 (8.3%) 76
    Agitation 20/271 (7.4%) 30 14/125 (11.2%) 24 11/305 (3.6%) 15 45/701 (6.4%) 69
    Depression 18/271 (6.6%) 23 7/125 (5.6%) 8 13/305 (4.3%) 15 38/701 (5.4%) 46
    Schizophrenia 24/271 (8.9%) 42 0/125 (0%) 0 0/305 (0%) 0 24/701 (3.4%) 42
    Aggression 1/271 (0.4%) 1 7/125 (5.6%) 8 1/305 (0.3%) 1 9/701 (1.3%) 10
    Respiratory, thoracic and mediastinal disorders
    Cough 11/271 (4.1%) 12 14/125 (11.2%) 16 14/305 (4.6%) 16 39/701 (5.6%) 44

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title CNS Medical Director
    Organization Sunovion Pharmaceuticals Inc.
    Phone 866-503-6351
    Email ClinicalTrialDisclosure@sunovion.com
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT01914393
    Other Study ID Numbers:
    • D1050302
    • 2013-001694-24
    First Posted:
    Aug 2, 2013
    Last Update Posted:
    Dec 19, 2019
    Last Verified:
    Dec 1, 2019