Pediatric Open-Label Extension Study

A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Depression; Autism
• Intervention / Treatment: Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed

• Study Type: Interventional
• Enrollment (Actual): 702
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score	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.	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in PANSS Positive Subscale Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in PANSS Negative Subscale Score	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.	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in PANSS General Psychopathology Subscale Score	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.	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in PANSS Excitability Subscale Score	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.	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in the Clinical Global Impression -Severity Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score	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	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	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.	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Clinical Global Impression (CGI) - Severity Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score	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.	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score	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	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	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.	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104
Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score	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	Open-Label Baseline, Week 28, Week 52, and Week 104

Collaborators and Investigators

• Sponsor: Sunovion
• Investigators: Study Director: Lurasidone Medical Director, MD, Sunovion

Publications and helpful links

General Publications

• DelBello MP, Tocco M, Pikalov A, Deng L, Goldman R. Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression. J Child Adolesc Psychopharmacol. 2021 Sep;31(7):494-503. doi: 10.1089/cap.2021.0040. Epub 2021 Jul 29.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2013
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: July 30, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Schizophrenia; Autism; Lurasidone; Latuda
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Bipolar Disorder; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: D1050302; 2013-001694-24 (EudraCT Number)