Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

PHASE3CompletedINTERVENTIONAL
Enrollment

683

Participants

Timeline

Start Date

May 18, 2016

Primary Completion Date

January 21, 2022

Study Completion Date

January 21, 2022

Conditions
Depressive Disorder, Major
Interventions
DRUG

Vortioxetine 10 mg/day

"10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).~Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed"

DRUG

Vortioxetine 20 mg/day

"20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).~Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed"

DRUG

Fluoxetine 20mg/day

"20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).~Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed"

OTHER

Placebo

Encapsulated tablet, orally

Trial Locations (98)

1021

Vadaskert Alapitvany, Budapest

1079

Children Hospilal -Gailezers, Riga

2196

Tara Hospital, Sandhurst

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula

7530

Cape Trial Centre, Bellville

7700

MHAT Targovishte AD, Targovisthe

9020

Diagnostic Consultative Center Mladost-M Varna OOD, Varna

10036

Manhattan Behavioral Medicine, New York

11000

Child and Adolescent Neurology and Psychiatry Clinic, Belgrade

Institute of Mental Health, Belgrade

11315

Marienthali Kliinik, Tallinn

14618

Finger Lakes Clinical Research, Rochester

15879

Prywatne Gabinety Lekarskie Promedicus, Bialystok

18000

Daily Hospital for Children and Adolescents, Pantelej-Nis

20010

Children's National Medical Center Merge, Washington D.C.

21000

Clinical Center of Vojvodina - Clinic of Psychiatry, Novi Sad

21205

Kennedy Krieger Institute, Baltimore

28922

Hospital Universitario Fundacion Alcorcon, Alcorcón

29620

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

30060

Northwest Behavioral Research Center, Marietta

30331

Atlanta Center for Medical Research, Atlanta

31000

ICARO Investigaciones en Medicina S.A. de C.V., Chihuahua City

32607

Sarkis Clinical Trials, Gainesville

32763

Medical Research Group of Central Florida, Orange City

34000

University Clinical Center Kragujevac, Kragujevac

35143

Sciaf Ulss 16 Padova, Padua

36013

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

38119

Research Strategies Of Memphis, Llc, Memphis

44012

University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry, Cleveland

44093

CHU de Nantes - Hopital Hotel Dieu, Nantes

44130

North Star Medical Research, LLC, Middleburg Heights

Centro Investigacion Medico Biologica Y Terapia Avanzada, Guadalajara

44200

Clinica Cemelli, Guadalajara

44690

Roberto Zepeda Sanchez, Guadalajara

45219

University of Cincinnati Medical Center, Cincinnati

46000

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

51050

E.S.E. Hospital Mental de Antioquia HOMO, Bello

55122

Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri, Mainz

56026

Scientific Institute Fondazione Stella Maris, Calambrone Pisa

58300

Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu, Wałbrzych

59500

Cabinet Psyche, Douai

60555

AMR Conventions Research, Warrenville

60563

AMR- Baber Research, Inc., Naperville

60612

American Medical Research, Inc., Chicago

63132

Millennium Psychiatric Associates, LLC, St Louis

63304

St. Charles Psychiatric Associates - Midwest Research Group, Saint Charles

64060

CRI Centro Regiomontano de Investigacion SC, Monterrey

65006

Odessa Regional Medical Centre of Mental Health, Odesa

67214

Kansas University School of Medicine-Wichita, Wichita

70629

Lake Charles Clinical Trials, Lake Charles

72211

Woodland International Research Group, Little Rock

73106

IPS Research Company, Oklahoma City

73118

Paradigm Research Professionals, LLC, Oklahoma City

75093

AIM Trials, LLC, Plano

Research Across America, Plano

78213

BIND Investigaciones S.C, San Luis Potosí City

78229

Clinical Trials of Texas, Inc., San Antonio

78759

BioBehavioral Research of Austin, Austin

78990

Centre Medical Ambroise Pare, Élancourt

80020

Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS., Barranquilla

80131

University Federico II Of Naples, Napoli

80230

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

82140

B & B Investigaciones Medicas, SC, Mazatlán

84015

Westside Medical, Clinton

84058

Aspen Clinical Research, LLC, Orem

90807

Alliance for Wellness dba Alliance for Research, Long Beach

91402

Asclepes Research Center, Panorama City

91945

Synergy Clinical Research Center, Lemon Grove

92251

Sun Valley Research Center, Imperial

92868

NRC Research Institute, Orange

111166

Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS, Bogotá

150003

Yaroslavl Regional Clinical Psychiatry Hospital, Yaroslavl

163530

Arkhangelsk Regional Clinical Mental Hospital, Arkhangelsk

197341

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

344010

Medicorehabilitation Research Center Phoenix, Rostov-on-Don

344022

Rostov State Medical University of the Minzdravsotsrazvitiya of Russia, Rostov-on-Don

350007

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

357034

Stavropol Region Psychiatric Hospital No.2, Stavropol

410028

Saratov State Medical University, Saratov

410060

Guz Saratov Regional Psychiatric Hospital St. Sofii, Saratov

413124

GUZ Engels Psychiatric Hospital, Engel's

620030

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

630091

LLC City Neurological Center Sibneuromed, Novosibirsk

634009

Nebbiolo LLC, Tomsk

4534708

Shalvata Mental Health Center, Hod HaSharon

5262000

The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital, Tel Litwinsky

6435807

Ramat Chen - Mental Health Clinic, Tel Aviv

08540

Princeton Medical Institute, Princeton

M5S 3A3

Paediatric Sleep Research Inc., Toronto

Unknown

Psynapsis Salud Mental S.A., Pereira

LV-3401

Linda Keruze's Psychiatric Center, LLC, Liepāja

04530

Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics), Mexico City

80-546

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

25-103

Przychodnia Syntonia Poradnia Zdrowia Psychicznego, Kielce

20-884

Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny, Lublin

60-744

Filip Rybakowski Specjalistyczna Praktyka Lekarska, Poznan

03080

Seoul National University Hospital, Seoul

04080

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

H. Lundbeck A/S

INDUSTRY