Clinical trial NCT02871297: Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Official title: Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: adolescent
children
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 662
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.


Eligibility criteria: Inclusion Criteria:

* The participant is a male or female child aged ≥7 and \<12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
* The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
* The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
* The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
* For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
* For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.

Exclusion Criteria:

* The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
* The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 30
Secondary outcomes:
measure: Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26
timeFrame: Baseline, Week 26
measure: Time to First Relapse
timeFrame: Baseline up to Week 26
measure: Time to First Loss of Remission
timeFrame: Baseline up to Week 26
measure: Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
timeFrame: Baseline, Week 26
measure: Clinical Global Impression - Global Improvement (CGI-I) Score
timeFrame: Week 26
measure: Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite (GEC) Score at Week 26
timeFrame: Baseline, Week 26
measure: Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the GEC Score at Week 26
timeFrame: Baseline, Week 26
measure: Children (7-11 Years): Change From Baseline in BRIEF-P Using the MI Score at Week 26
timeFrame: Baseline, Week 26
measure: Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the MI Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26
timeFrame: Baseline, Week 26
measure: Number of Participants With Response to the Palatability Questionnaire
timeFrame: assessed at Baseline up to Week 26, Week 26 reported
measure: Number of Participants With Response to the Acceptability Questionnaire
timeFrame: assessed at Baseline up to Week 26, Week 26 reported
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Sarver Heart Center (SHC)
state: Arizona
city: Wichita
country: United States
facility: Kansas University School of Medicine-Wichita
state: Kansas
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
state: Ohio
city: Targovishte
country: Bulgaria
facility: MHAT Targovishte AD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Center Mladost-M Varna OOD
city: Toronto
country: Canada
facility: Paediatric Sleep Research Inc.
state: Ontario
city: Bello
country: Colombia
facility: E.S.E. Hospital Mental de Antioquia HOMO
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
state: Atlantico
city: Bogota
country: Colombia
facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
state: DC
city: Pereira
country: Colombia
facility: Psynapsis Salud Mental S.A.
state: Risaralda
city: Tallinn
country: Estonia
facility: Marienthali Kliinik
city: Douai
country: France
facility: Cabinet Psyche
state: Nord
city: Elancourt
country: France
facility: Centre Medical Ambroise Pare
city: Nantes Cedex 1
country: France
facility: CHU de Nantes - Hopital Hotel Dieu
city: Freiburg
country: Germany
facility: Univ. Freiburg
state: Baden-Wurttemberg
city: Mainz
country: Germany
facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
city: Maulbronn
country: Germany
facility: Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen -
city: Budapest
country: Hungary
facility: Vadaskert Child Psychiatric Hospital and Outpatient
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
city: Tel Aviv
country: Israel
facility: Ramat Chen - Mental Health Clinic
city: Calambrone
country: Italy
facility: Scientific Institute Fondazione Stella Maris
state: Pisa
city: Padova
country: Italy
facility: Sciaf Ulss 16 Padova
state: Regione Veneto
city: Cagliari
country: Italy
facility: Hospital Trust-University of Cagliari
city: Genova
country: Italy
facility: U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini
city: Messina
country: Italy
facility: Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino
city: Napoli
country: Italy
facility: University Federico II Of Naples
city: Cheonan-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
state: Chungcheongnam-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Jelgava
country: Latvia
facility: Hospital Gintermuiza
city: Liepaja
country: Latvia
facility: Linda Keruze's Psychiatric Center, LLC
city: Riga
country: Latvia
facility: Children Hospilal -Gailezers
city: Sigulda
country: Latvia
facility: Sigulda Hospital Outpatient Clinic
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Clinica Cemelli
state: Jalisco
city: Guadalajara
country: Mexico
facility: Roberto Zepeda Sanchez
state: Jalisco
city: Monterrey
country: Mexico
facility: CRI Centro Regiomontano de Investigacion SC
state: Nuevo Leon
city: Culiacan De Rosales
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C
state: Sinaloa
city: Mazatlan
country: Mexico
facility: B & B Investigaciones Medicas, SC
state: Sinaloa
city: San Luis Potosi
country: Mexico
facility: BIND Investigaciones S.C
city: Bialystok
country: Poland
facility: Prywatne Gabinety Lekarskie Promedicus
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
city: Kielce
country: Poland
facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego
city: Lublin
country: Poland
facility: Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny
city: Poznan
country: Poland
facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska
city: Walbrzych
country: Poland
facility: Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu
city: Wroclaw
country: Poland
facility: Centrum Neuropsychiatrii Neuromed
city: Rostov-On-Don
country: Russian Federation
facility: Medicorehabilitation Research Center Phoenix
state: Rostov State
city: Stavropol
country: Russian Federation
facility: Stavropol Region Psychiatric Hospital No.2
state: Stavropol Region
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Mental Hospital
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk Region Â¿Sverdlovsk Regional Clinical Psychi...
city: Engels
country: Russian Federation
facility: GUZ Engels Psychiatric Hospital
city: Krasnodar
country: Russian Federation
facility: State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...
city: Lipetsk
country: Russian Federation
facility: Lipetsk Regional Psychoneurological Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
city: Novosibirsk
country: Russian Federation
facility: LLC City Neurological Center Sibneuromed
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Saratov
country: Russian Federation
facility: Guz Saratov Regional Psychiatric Hospital St. Sofii
city: St-Petersburg
country: Russian Federation
facility: City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov
city: Tomsk
country: Russian Federation
facility: Nebbiolo LLC
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Psychiatry Hospital
city: Belgrade
country: Serbia
facility: Child and Adolescent Neurology and Psychiatry Clinic
city: Belgrade
country: Serbia
facility: Institute of Mental Health
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina - Clinic of Psychiatry
city: Pantelej-Nis
country: Serbia
facility: Daily Hospital for Children and Adolescents
city: Bellville
country: South Africa
facility: Cape Trial Centre
state: Cape Town
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Torremolinos
country: Spain
facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
state: Malaga
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Kyiv
country: Ukraine
facility: Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...
city: Odessa
country: Ukraine
facility: Odessa Regional Medical Centre of Mental Health
city: Poltava
country: Ukraine
facility: Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...
city: Ternopil
country: Ukraine
facility: Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...
city: Liverpool
country: United Kingdom
facility: Alder Hey Hospital
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: