Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
NCT ID: NCT03108625
Last Updated: 2021-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
94 participants
INTERVENTIONAL
2017-03-01
2020-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vortioxetine
Once daily dosing of vortioxetine (oral tablets) for 78 weeks.
Vortioxetine
Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Interventions
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Vortioxetine
Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must have completed extension Study 12712A immediately prior to enrolment into this extension study.
* The patient had a primary diagnosis of a MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5™.
* The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator.
Exclusion Criteria
* The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.
7 Years
17 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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MHAT "Targovishte" AD
Targovishte, , Bulgaria
DCC Mladost-M
Varna, , Bulgaria
Marienthal Center of Psychiatry and Psychology
Tallinn, , Estonia
CHU de Nantes - Hopital Hotel Dieu
Nantes, , France
Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
Mainz, , Germany
Vadaskert Alapitvany
Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, , Hungary
Scientific Institute Fondazione Stella Maris
Calambrone, , Italy
Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
Messina, , Italy
Linda Keruze's Psychiatric Center, LLC
Liepāja, , Latvia
Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak
Bialystok, , Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, , Poland
Przychodnia Syntonia Poradnia Zdrowia Psychicznego
Kielce, , Poland
SPECTRUM Centrum Neurologii i Psychiatrii
Lublin, , Poland
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"
Wroclaw, , Poland
Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health
Krasnodar, , Russia
Lipetsk Regional Psychoneurological Hospital
Lipetsk, , Russia
Nizhny Novgorod Region State Institution Of Healthcare
Nizhny Novgorod, , Russia
Medicorehabilitation Research Center "Phoenix"
Rostov-on-Don, , Russia
Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
Rostov-on-Don, , Russia
Guz "Saratov Regional Psychiatric Hospital St. Sofii"
Saratov, , Russia
Saratov State Medical University
Saratov, , Russia
State Budgetary Healthcare Institution
Tonnel'nyy, , Russia
State Budgetary Healthcare Institution of Sverdlovsk Region
Yekaterinburg, , Russia
Clinic of Neurology and Psychiatry for Children and Adolescents
Belgrade, , Serbia
Clinical Center of Vojvodina - Clinic of Psychiatry
Novi Sad, , Serbia
Cape Trial Centre
Bellville, , South Africa
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
Torremolinos, , Spain
Alder Hey Childrens Hospital
Liverpool, , United Kingdom
Countries
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Other Identifiers
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2015-002658-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12712B
Identifier Type: -
Identifier Source: org_study_id
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