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

NCT02871297 | Terminated Phase 3 Results DMC

• 2 other identifiers: 12712A2008-005356-25
• Study Type: interventional
• Target: 662
• Locations: 19 countries
• Sites: 77

Brief Summary

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.

Conditions

Depressive Disorder, Major

Keywords

adolescent; children

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAE was defined as an AE that started or increased in intensity on or after the date of first dose of study drug in this study 12712A. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.

  Baseline up to Week 30

Secondary Outcomes (13)

• Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26

  Baseline, Week 26

• Time to First Relapse

  Baseline up to Week 26

• Time to First Loss of Remission

  Baseline up to Week 26

• Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26

  Baseline, Week 26

• Clinical Global Impression - Global Improvement (CGI-I) Score

  Week 26

Study Arms (1)

Vortioxetine

EXPERIMENTAL

Vortioxetine tablets for 26 weeks. Single dose of vortioxetine oral drops (only a subset of participants).

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

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

Also known as: Brintellix (R), Lu AA21004

Vortioxetine

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The participant is a male or female child aged ≥7 and \<12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
• 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.

You may not qualify if:

• The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
• The participant 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 (78)

The University of Arizona Sarver Heart Center (SHC)

Tucson, Arizona, 85724, United States

Location

Kansas University School of Medicine-Wichita

Wichita, Kansas, 67214, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry

Cleveland, Ohio, 44012, United States

Location

MHAT Targovishte AD

Targovishte, 7700, Bulgaria

Location

Diagnostic Consultative Center Mladost-M Varna OOD

Varna, 9020, Bulgaria

Location

Paediatric Sleep Research Inc.

Toronto, Ontario, M5S 3A3, Canada

Location

E.S.E. Hospital Mental de Antioquia HOMO

Bello, Antioquia, 51050, Colombia

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

Barranquilla, Atlántico, 80020, Colombia

Location

Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

Bogotá, DC, 111166, Colombia

Location

Psynapsis Salud Mental S.A.

Pereira, Risaralda Department, Colombia

Location

Marienthali Kliinik

Tallinn, 11315, Estonia

Location

Cabinet Psyche

Douai, Nord, 59500, France

Location

Centre Medical Ambroise Pare

Élancourt, 78990, France

Location

CHU de Nantes - Hopital Hotel Dieu

Nantes, 44093, France

Location

Univ. Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

Mainz, 55122, Germany

Location

Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH

Maulbronn, 75433, Germany

Location

University Hospital Tuebingen -

Tübingen, 72076, Germany

Location

Vadaskert Child Psychiatric Hospital and Outpatient

Budapest, 1021, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, 5700, Hungary

Location

Ramat Chen - Mental Health Clinic

Tel Aviv, 6435807, Israel

Location

Scientific Institute Fondazione Stella Maris

Calambrone, Pisa, 56026, Italy

Location

Sciaf Ulss 16 Padova

Padua, Regione Veneto, 35143, Italy

Location

Hospital Trust-University of Cagliari

Cagliari, 09121, Italy

Location

U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini

Genova, 16147, Italy

Location

Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino

Messina, 98125, Italy

Location

University Federico II Of Naples

Napoli, 80131, Italy

Location

Hospital Gintermuiza

Jelgava, 3008, Latvia

Location

Linda Keruze's Psychiatric Center, LLC

Liepāja, LV-3401, Latvia

Location

Children Hospilal -Gailezers

Riga, 1079, Latvia

Location

Sigulda Hospital Outpatient Clinic

Sigulda, LV-2150, Latvia

Location

Clinica Cemelli

Guadalajara, Jalisco, 44200, Mexico

Location

Roberto Zepeda Sanchez

Guadalajara, Jalisco, 44690, Mexico

Location

Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

Mexico City, Mexico City, 04530, Mexico

Location

CRI Centro Regiomontano de Investigacion SC

Monterrey, Nuevo León, 64000, Mexico

Location

Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C

Culiacan de Rosales, Sinaloa, 80230, Mexico

Location

B & B Investigaciones Medicas, SC

Mazatlán, Sinaloa, 82140, Mexico

Location

BIND Investigaciones S.C

San Luis Potosí City, 78213, Mexico

Location

Prywatne Gabinety Lekarskie Promedicus

Bialystok, Podlaskie Voivodeship, 15879, Poland

Location

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

Gdansk, 80-546, Poland

Location

Przychodnia Syntonia Poradnia Zdrowia Psychicznego

Kielce, 25-103, Poland

Location

Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny

Lublin, 20-884, Poland

Location

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, 60-744, Poland

Location

Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu

Wałbrzych, 58300, Poland

Location

Centrum Neuropsychiatrii Neuromed

Wroclaw, 54-235, Poland

Location

Medicorehabilitation Research Center Phoenix

Rostov-on-Don, Rostov State, 344010, Russia

Location

Stavropol Region Psychiatric Hospital No.2

Stavropol, Stavropol Kray, 357034, Russia

Location

Arkhangelsk Regional Clinical Mental Hospital

Arkhangelsk, 163530, Russia

Location

GUZ Engels Psychiatric Hospital

Engel's, 413124, Russia

Location

State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...

Krasnodar, 350007, Russia

Location

Lipetsk Regional Psychoneurological Hospital

Lipetsk, 398007, Russia

Location

Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...

Nizhny Novgorod, 603155, Russia

Location

LLC City Neurological Center Sibneuromed

Novosibirsk, 630091, Russia

Location

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

Rostov-on-Don, 344022, Russia

Location

City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov

Saint Petersburg, 197341, Russia

Location

Saratov State Medical University

Saratov, 410028, Russia

Location

Guz Saratov Regional Psychiatric Hospital St. Sofii

Saratov, 410060, Russia

Location

Nebbiolo LLC

Tomsk, 634009, Russia

Location

Yaroslavl Regional Clinical Psychiatry Hospital

Yaroslavl, 150003, Russia

Location

State Budgetary Healthcare Institution of Sverdlovsk Region ¿Sverdlovsk Regional Clinical Psychi...

Yekaterinburg, 620030, Russia

Location

Child and Adolescent Neurology and Psychiatry Clinic

Belgrade, 11000, Serbia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical Center of Vojvodina - Clinic of Psychiatry

Novi Sad, 21000, Serbia

Location

Daily Hospital for Children and Adolescents

Pantelej-Nis, 18000, Serbia

Location

Cape Trial Centre

Bellville, Cape Town, 7530, South Africa

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan-si, Chungcheongnam-do, 31151, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

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

Torremolinos, Malaga, 29620, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28009, Spain

Location

Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...

Kyiv, 04080, Ukraine

Location

Odessa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

Location

Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...

Poltava, 36013, Ukraine

Location

Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...

Ternopil, 46000, Ukraine

Location

NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...

Glasgow, G51 4TF, United Kingdom

Location

Alder Hey Hospital

Liverpool, L12 2AP, 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

Limitations and Caveats

The study was terminated early based on new efficacy data from another study.

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 15, 2016
• First Posted: August 18, 2016
• Study Start: August 17, 2016
• Primary Completion: March 25, 2022
• Study Completion: April 19, 2022
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-11

Locations

LA (4); GB (2); DE (4); ME (7); CO (4); PL (7); RU (15); IL (1); SE (5); ZA (1); UA (4); ES (3); KR (2); IT (6); CA (1); US (4); BU (2); FR (3); HU (2)