Clinical trial NCT03108625: Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
Official title: Long-term, Open-label, Flexible-dose, Continuation Extension Study With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: children
adolescent
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 94
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
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 patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD


Eligibility criteria: Inclusion Criteria:

* The patient is a male or female child aged ≥7 and \<12 years or an adolescent aged ≥12 and ≤17 years at Baseline in Study 12712B.
* 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 been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12712A.
* The patient 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: Incidence of Treatment-Emergent Adverse Events (Safety)
timeFrame: Up to Week 104
Secondary outcomes:
measure: Change in CDRS-R total score
timeFrame: Change from study 12712A baseline to Week 104
measure: Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
timeFrame: Up to Week 104
measure: Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)
timeFrame: Up to Week 104
measure: Change in CGI-S score
timeFrame: Change from study 12712A baseline to Week 104
measure: CGI-I score
timeFrame: Week 104
measure: Children (7-11 years): change in BRIEF using the Global Executive Composite score
timeFrame: Change from study 12712A baseline to Week 104
measure: Children (7-11 years): change in BRIEF using the Megacognition Index
timeFrame: Change from study 12712A baseline to Week 104
measure: Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score
timeFrame: Change from study 12712A baseline to Week 104
measure: Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index
timeFrame: Change from study 12712A baseline to Week 104
measure: Change in CGAS score
timeFrame: Change from study 12712A baseline to Week 104
measure: Change in PedsQL VAS score
timeFrame: Change from study 12712A baseline to Week 104
Other outcomes:
Locations:
city: Targovishte
country: Bulgaria
facility: MHAT "Targovishte" AD
city: Varna
country: Bulgaria
facility: DCC Mladost-M
city: Tallinn
country: Estonia
facility: Marienthal Center of Psychiatry and Psychology
city: Nantes
country: France
facility: CHU de Nantes - Hopital Hotel Dieu
city: Mainz
country: Germany
facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri
city: Budapest
country: Hungary
facility: Vadaskert Alapitvany
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
city: Calambrone
country: Italy
facility: Scientific Institute Fondazione Stella Maris
city: Messina
country: Italy
facility: Universita degli Studi di Messina - Facolta di Medicina e Chirurgia
city: Liepāja
country: Latvia
facility: Linda Keruze's Psychiatric Center, LLC
city: Białystok
country: Poland
facility: Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak
city: Gdańsk
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 Neurologii i Psychiatrii
city: Poznań
country: Poland
facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska
city: Wrocław
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk Region
city: Krasnodar
country: Russian Federation
facility: Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health
city: Lipetsk
country: Russian Federation
facility: Lipetsk Regional Psychoneurological Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Region State Institution Of Healthcare
city: Rostov-on-Don
country: Russian Federation
facility: Medicorehabilitation Research Center "Phoenix"
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia
city: Saratov
country: Russian Federation
facility: Guz "Saratov Regional Psychiatric Hospital St. Sofii"
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Tonnel'nyy
country: Russian Federation
facility: State Budgetary Healthcare Institution
city: Belgrade
country: Serbia
facility: Clinic of Neurology and Psychiatry for Children and Adolescents
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina - Clinic of Psychiatry
city: Bellville
country: South Africa
facility: Cape Trial Centre
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Torremolinos
country: Spain
facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo
city: Liverpool
country: United Kingdom
facility: Alder Hey Childrens Hospital
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: