Clinical trial NCT01914393: Pediatric Open-Label Extension Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Autism
Bipolar Depression
Keywords: Schizophrenia
Autism
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-02
Enrollment: 702
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)
timeFrame: During 104 Weeks (2-years) treatment period
Secondary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in PANSS Positive Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in PANSS Negative Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in PANSS General Psychopathology Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in PANSS Excitability Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in the Clinical Global Impression -Severity Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Clinical Global Impression (CGI) - Severity Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
measure: Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score
timeFrame: Open-Label Baseline, Week 28, Week 52, and Week 104
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Downey
country: United States
facility: Diligent Clinical Trials, Inc
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials - Parent
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: University of South Florida
state: Florida
city: Sanford
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida Rothman Center of Neuropychiatry
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Attalla Consultants, LLC
state: Georgia
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
state: Louisiana
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Bloomfield Hills
country: United States
facility: Neurobehavioral medicine Group, LLC
state: Michigan
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates
state: Missouri
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Glen Oaks
country: United States
facility: North Shore/Long Island Jewish PRIME
state: New York
city: Mount Kisco
country: United States
facility: Dr. Jeanette Cueva
state: New York
city: New York
country: United States
facility: Montefiore Medical Center PRIME
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Nisonger Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands, P.A.
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development, LLC
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Herndon
country: United States
facility: Neuroscience, Inc.
state: Virginia
city: Petersburg
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Ruse
country: Bulgaria
facility: MHC - Ruse, EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska" EAD
city: Targovishte
country: Bulgaria
facility: MHAT-Targovishte, AD
city: Varna
country: Bulgaria
facility: DCC "Mladost M" - Varna, OOD
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia
city: Bogota
country: Colombia
facility: Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
city: Nantes Cedex 1
country: France
facility: CHU Nantes - Hôpital Mère-Enfant
city: Budapest
country: Hungary
facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Culiacan
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
state: Sinaloa
city: Durango
country: Mexico
facility: Dr. Jessica Rosas Escobar
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
city: Monterrey
country: Mexico
facility: Instituto de Informacion de Investigacion en Salud Mental
city: Nuevo León
country: Mexico
facility: Av Modesto Arreola #917 Ote. Col Centro
city: Davao City
country: Philippines
facility: Alexian Brothers Health and Wellness Center
city: Iloilo
country: Philippines
facility: West Visayas State University Medical Center
city: Mandaluyong City
country: Philippines
facility: National Center for Mental Health
city: Quezon City
country: Philippines
facility: Veterans Memorial Medical Center
city: Kobierzyce
country: Poland
facility: NZOZ Poradnia Zdrowia Psychicznego
city: Toruń
country: Poland
facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy
city: Caguas
country: Puerto Rico
facility: Centro de Investigacion Clinica Psiquiatrica
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
city: Iasi
country: Romania
facility: Spitalul Clinic de Psihiatrie Socola
city: Timisoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
city: Ekaterinburg
country: Russian Federation
facility: Sverdiovsk Regional Clinical Psychiatric Hospital
city: Lipetsk
country: Russian Federation
facility: GUZ Lipetsk Regional psychoneurological Hospital #1
city: Moscow
country: Russian Federation
facility: Closed corporation "Scientific Center of Personalized Psychiatry"
city: Moscow
country: Russian Federation
facility: Scientific Center of Personalized Psychiatry
city: Nizhny Novgorod
country: Russian Federation
facility: State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod"
city: Saint Petersburg
country: Russian Federation
facility: SHI "City Psychoneurological dispensary #7 (with Hospital)"
city: Saint Petersburg
country: Russian Federation
facility: Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin
city: Saint Petersburg
country: Russian Federation
facility: Bekhterev Institute
city: Saratow
country: Russian Federation
facility: Regional Clinical Mental Hospital of Saint Sofiya
city: Tomsk
country: Russian Federation
facility: FSBSI "Scientific Research Institute of Mental Health"
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital"
city: Torremolinos
country: Spain
facility: Hospital Marítimo de Torremolinos
state: Málaga
city: Ivano Frankivsk
country: Ukraine
facility: RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU
city: Kharkiv
country: Ukraine
facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU
city: Kharkiv
country: Ukraine
facility: SI Institute of Children and Adolescents Healthcare of NAMSU
city: Kyiv
country: Ukraine
facility: TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions
city: Lviv
country: Ukraine
facility: CI Lviv Regional Clinical Psychiatric Hospital
city: Odesa
country: Ukraine
facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept.
city: Poltava
country: Ukraine
facility: O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy
city: Stepanivka
country: Ukraine
facility: CI Kherson Regional Psychiatric Hospital of Kherson RC
city: Ternopil
country: Ukraine
facility: Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU
city: Vinnitsia
country: Ukraine
facility: Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Lurasidone Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.