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
NCT ID: NCT02871297
Last Updated: 2022-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
662 participants
INTERVENTIONAL
2016-08-17
2022-04-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vortioxetine
Vortioxetine tablets for 26 weeks. Single dose of vortioxetine oral drops (only a subset of participants).
Vortioxetine
Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vortioxetine
Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.
7 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
H. Lundbeck A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Arizona Sarver Heart Center (SHC)
Tucson, Arizona, United States
Kansas University School of Medicine-Wichita
Wichita, Kansas, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry
Cleveland, Ohio, United States
MHAT Targovishte AD
Targovishte, , Bulgaria
Diagnostic Consultative Center Mladost-M Varna OOD
Varna, , Bulgaria
Paediatric Sleep Research Inc.
Toronto, Ontario, Canada
E.S.E. Hospital Mental de Antioquia HOMO
Bello, Antioquia, Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.
Barranquilla, Atlántico, Colombia
Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS
Bogotá, DC, Colombia
Psynapsis Salud Mental S.A.
Pereira, Risaralda Department, Colombia
Marienthali Kliinik
Tallinn, , Estonia
Cabinet Psyche
Douai, Nord, France
Centre Medical Ambroise Pare
Élancourt, , France
CHU de Nantes - Hopital Hotel Dieu
Nantes, , France
Univ. Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
Mainz, , Germany
Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH
Maulbronn, , Germany
University Hospital Tuebingen -
Tübingen, , Germany
Vadaskert Child Psychiatric Hospital and Outpatient
Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, , Hungary
Ramat Chen - Mental Health Clinic
Tel Aviv, , Israel
Scientific Institute Fondazione Stella Maris
Calambrone, Pisa, Italy
Sciaf Ulss 16 Padova
Padua, Regione Veneto, Italy
Hospital Trust-University of Cagliari
Cagliari, , Italy
U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini
Genova, , Italy
Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino
Messina, , Italy
University Federico II Of Naples
Napoli, , Italy
Hospital Gintermuiza
Jelgava, , Latvia
Linda Keruze's Psychiatric Center, LLC
Liepāja, , Latvia
Children Hospilal -Gailezers
Riga, , Latvia
Sigulda Hospital Outpatient Clinic
Sigulda, , Latvia
Clinica Cemelli
Guadalajara, Jalisco, Mexico
Roberto Zepeda Sanchez
Guadalajara, Jalisco, Mexico
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City, Mexico City, Mexico
CRI Centro Regiomontano de Investigacion SC
Monterrey, Nuevo León, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C
Culiacan de Rosales, Sinaloa, Mexico
B & B Investigaciones Medicas, SC
Mazatlán, Sinaloa, Mexico
BIND Investigaciones S.C
San Luis Potosí City, , Mexico
Prywatne Gabinety Lekarskie Promedicus
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, , Poland
Przychodnia Syntonia Poradnia Zdrowia Psychicznego
Kielce, , Poland
Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny
Lublin, , Poland
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan, , Poland
Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu
Wałbrzych, , Poland
Centrum Neuropsychiatrii Neuromed
Wroclaw, , Poland
Medicorehabilitation Research Center Phoenix
Rostov-on-Don, Rostov State, Russia
Stavropol Region Psychiatric Hospital No.2
Stavropol, Stavropol Kray, Russia
Arkhangelsk Regional Clinical Mental Hospital
Arkhangelsk, , Russia
GUZ Engels Psychiatric Hospital
Engel's, , Russia
State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...
Krasnodar, , Russia
Lipetsk Regional Psychoneurological Hospital
Lipetsk, , Russia
Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...
Nizhny Novgorod, , Russia
LLC City Neurological Center Sibneuromed
Novosibirsk, , Russia
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-on-Don, , Russia
City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov
Saint Petersburg, , Russia
Saratov State Medical University
Saratov, , Russia
Guz Saratov Regional Psychiatric Hospital St. Sofii
Saratov, , Russia
Nebbiolo LLC
Tomsk, , Russia
Yaroslavl Regional Clinical Psychiatry Hospital
Yaroslavl, , Russia
State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi...
Yekaterinburg, , Russia
Child and Adolescent Neurology and Psychiatry Clinic
Belgrade, , Serbia
Institute of Mental Health
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Clinical Center of Vojvodina - Clinic of Psychiatry
Novi Sad, , Serbia
Daily Hospital for Children and Adolescents
Pantelej-Nis, , Serbia
Cape Trial Centre
Bellville, Cape Town, South Africa
Soon Chun Hyang University Hospital Cheonan
Cheonan-si, Chungcheongnam-do, South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, Spain
Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
Torremolinos, Malaga, Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...
Kyiv, , Ukraine
Odessa Regional Medical Centre of Mental Health
Odesa, , Ukraine
Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...
Poltava, , Ukraine
Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...
Ternopil, , Ukraine
NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...
Glasgow, , United Kingdom
Alder Hey Hospital
Liverpool, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-005356-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12712A
Identifier Type: -
Identifier Source: org_study_id