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

NCT03108625 | Completed Phase 3 DMC

• 2 other identifiers: 12712B2015-002658-11
• Study Type: interventional
• Target: 94
• Locations: 12 countries
• Sites: 30

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

Conditions

Depressive Disorder, Major

Keywords

children; adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in CDRS-R total score

  Change from study 12712A baseline to Week 104

• Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)

  Up to Week 104

• Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)

  Up to Week 104

• Change in CGI-S score

  Change from study 12712A baseline to Week 104

• CGI-I score

  Week 104

Study Arms (1)

Vortioxetine

EXPERIMENTAL

Once daily dosing of vortioxetine (oral tablets) for 78 weeks.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

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

Also known as: Brintellix, Lu AA21004

Vortioxetine

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (31)

MHAT "Targovishte" AD

Targovishte, Bulgaria

Location

DCC Mladost-M

Varna, Bulgaria

Location

Marienthal Center of Psychiatry and Psychology

Tallinn, Estonia

Location

CHU de Nantes - Hopital Hotel Dieu

Nantes, France

Location

Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

Mainz, Germany

Location

Vadaskert Alapitvany

Budapest, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, Hungary

Location

Scientific Institute Fondazione Stella Maris

Calambrone, Italy

Location

Universita degli Studi di Messina - Facolta di Medicina e Chirurgia

Messina, Italy

Location

Linda Keruze's Psychiatric Center, LLC

Liepāja, Latvia

Location

Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak

Bialystok, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, Poland

Location

Przychodnia Syntonia Poradnia Zdrowia Psychicznego

Kielce, Poland

Location

SPECTRUM Centrum Neurologii i Psychiatrii

Lublin, Poland

Location

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"

Wroclaw, Poland

Location

Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health

Krasnodar, Russia

Location

Lipetsk Regional Psychoneurological Hospital

Lipetsk, Russia

Location

Nizhny Novgorod Region State Institution Of Healthcare

Nizhny Novgorod, Russia

Location

Medicorehabilitation Research Center "Phoenix"

Rostov-on-Don, Russia

Location

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

Rostov-on-Don, Russia

Location

Guz "Saratov Regional Psychiatric Hospital St. Sofii"

Saratov, Russia

Location

Saratov State Medical University

Saratov, Russia

Location

State Budgetary Healthcare Institution

Tonnel’nyy, Russia

Location

State Budgetary Healthcare Institution of Sverdlovsk Region

Yekaterinburg, Russia

Location

Clinic of Neurology and Psychiatry for Children and Adolescents

Belgrade, Serbia

Location

Clinical Center of Vojvodina - Clinic of Psychiatry

Novi Sad, Serbia

Location

Cape Trial Centre

Bellville, South Africa

Location

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Location

Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

Torremolinos, Spain

Location

Alder Hey Childrens Hospital

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: April 11, 2017
• Study Start: March 1, 2017
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

ES (2); GB (1); SE (2); IT (2); BU (2); DE (1); PL (6); LA (1); ZA (1); FR (1); HU (2); RU (9)