Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108625
• Other study ID #: 12712B
• Secondary ID: 2015-002658-11
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2017
• Est. completion date: April 16, 2020

Study information

• Verified date: June 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Vortioxetine
Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.

Locations

Country	Name	City	State
Bulgaria	MHAT "Targovishte" AD	Targovishte
Bulgaria	DCC Mladost-M	Varna
Estonia	Marienthal Center of Psychiatry and Psychology	Tallinn
France	CHU de Nantes - Hopital Hotel Dieu	Nantes
Germany	Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri	Mainz
Hungary	Vadaskert Alapitvany	Budapest
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza	Gyula
Italy	Scientific Institute Fondazione Stella Maris	Calambrone
Italy	Universita degli Studi di Messina - Facolta di Medicina e Chirurgia	Messina
Latvia	Linda Keruze's Psychiatric Center, LLC	Liepaja
Poland	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
Russian Federation	State Budgetary Healthcare Institution of Sverdlovsk Region	Ekaterinburg
Russian Federation	Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health	Krasnodar
Russian Federation	Lipetsk Regional Psychoneurological Hospital	Lipetsk
Russian Federation	Nizhny Novgorod Region State Institution Of Healthcare	Nizhny Novgorod
Russian Federation	Medicorehabilitation Research Center "Phoenix"	Rostov-on-Don
Russian Federation	Rostov State Medical University of the Minzdravsotsrazvitiya of Russia	Rostov-on-Don
Russian Federation	Guz "Saratov Regional Psychiatric Hospital St. Sofii"	Saratov
Russian Federation	Saratov State Medical University	Saratov
Russian Federation	State Budgetary Healthcare Institution	Tonnel'nyy
Serbia	Clinic of Neurology and Psychiatry for Children and Adolescents	Belgrade
Serbia	Clinical Center of Vojvodina - Clinic of Psychiatry	Novi Sad
South Africa	Cape Trial Centre	Bellville
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo	Torremolinos
United Kingdom	Alder Hey Childrens Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Bulgaria,  Estonia,  France,  Germany,  Hungary,  Italy,  Latvia,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events (Safety)	Based on safety assessments (e.g. paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS	Up to Week 104
Secondary	Change in CDRS-R total score	Children Depression Rating Scale, revised version	Change from study 12712A baseline to Week 104
Secondary	Number of relapses (CDRS-R =40 with a history of 2 weeks of clinical deterioration)	Number of relapses (CDRS-R =40 with a history of 2 weeks of clinical deterioration)	Up to Week 104
Secondary	Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)	Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)	Up to Week 104
Secondary	Change in CGI-S score	Clinical Global Impression - Severity of Illness	Change from study 12712A baseline to Week 104
Secondary	CGI-I score	Clinical Global Impression - Global Improvement	Week 104
Secondary	Children (7-11 years): change in BRIEF using the Global Executive Composite score	Behaviour Rating Inventory of Executive Function	Change from study 12712A baseline to Week 104
Secondary	Children (7-11 years): change in BRIEF using the Megacognition Index	Behaviour Rating Inventory of Executive Function	Change from study 12712A baseline to Week 104
Secondary	Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score	Behaviour Rating Inventory of Executive Function, Self-report version	Change from study 12712A baseline to Week 104
Secondary	Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index	Behaviour Rating Inventory of Executive Function, Self-report version	Change from study 12712A baseline to Week 104
Secondary	Change in CGAS score	Children's Global Assessment Scale	Change from study 12712A baseline to Week 104
Secondary	Change in PedsQL VAS score	Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales	Change from study 12712A baseline to Week 104