Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)

PHASE3CompletedINTERVENTIONAL
Enrollment

784

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

July 2, 2019

Study Completion Date

July 30, 2019

Conditions
Depressive Disorder, Major
Interventions
DRUG

Vortioxetine 10 mg/day

10 mg/day, encapsulated tablet (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 (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 20 mg/day

20 mg/day, encapsulated tablet (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

Trial Locations (124)

Unknown

US1369, Dothan

US1333, Tucson

US1310, Little Rock

US1062, Costa Mesa

US1387, Downey

US1114, Escondido

US1118, Glendale

US1123, Imperial

US1160 Renew Behavioral Health, Inc., Long Beach

US1368, Orange

US1370, Panorama City

US1351, Wildomar

US1133, Washington D.C.

US1217, Gainesville

US1229, Orange City

US1009, Atlanta

US1313, Marietta

US1311, Naperville

US1315, Naperville

US1103, Oak Brook

US1386, Wichita

US1261, Lake Charles

US1015, Baltimore

US1385 Ericksen Research And Development, Clinton

US1064, Creve Coeur

US1314, O'Fallon

US1266, Saint Charles

US1312, Berlin

US1222, Princeton

US1317, New York

US1171, Rochester

US1190, Staten Island

US1051, Cincinnati

US1054, Cleveland

US1334, Middleburg Heights

US1323, Oklahoma City

US1329, Oklahoma City

US1328, Austin

US1320, Plano

US1162, San Antonio

US1308, Orem

US1309, Richmond

BG1023, Targovishte

BG1025, Varna

CA1036 University of Calgary, Calgary

CA1038, Toronto

CO1003, Barranquilla

CO1001, Bello

CO1004, Bogotá

CO1002, Pereira

EE1007, Tallinn

EE1015, Viljandi

FR1041, Douai

FR1017, Élancourt

FR1009, Nantes

DE1078, Freiburg im Breisgau

DE1034, Mainz

DE1077, Mannheim

DE1081, Maulbronn

DE1076, Tübingen

HU1023, Budapest

HU1020, Gyula

IT1075, Cagliari

IT1073, Genova

IT1029, Messina

IT1068, Napoli

IT1074, Padua

IT1070, Pisa

IT1072 Osppedale Bambin gesu, Rome

LV1002, Jelgava

LV1008, Liepāja

LV1009, Riga

LV1007, Sigulda

MX1014, Culiacán

MX1011, Guadalajara

MX1013, Guadalajara

MX1022, Guadalajara

MX1023, Mazatlán

MX1003, Mexico City

MX1001, Nuevo León

PL1002, Bialystok

PL1050, Gdansk

PL1068, Kielce

PL1057, Lublin

PL1052, Poznan

PL1054, Wąbrzeźno

PL1051, Wroclaw

RU1009, Arkhangelsk

RU1059, Engel's

RU1046, Krasnodar

RU1011, Lipetsk

RU1004, Nizhny Novgorod

RU1010, Novosibirsk

RU1012, Rostov-on-Don

RU1044, Rostov-on-Don

RU1030, Saint Petersburg

RU1013, Saratov

RU1038, Saratov

RU1057, Tomsk

RU1048, Tonnel'nyy

RU1016, Yekaterinburg

RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents, Belgrade

RS1010, Belgrade

RS1011, Kragujevac

RS1003, Niš

RS1007, Novi Sad

ZA1019, Cape Town

ZA1022, Randburg

ZA1023, Sandton

KR1035, Cheonan

UA1037, Gyeongsang

KR1032, Seoul

KR1038, Seoul

ES1041, Alcorcón

ES1044, Madrid

ES1043, Pamplona

ES1018 Hospital de Sabadell, Sabadell

ES1040, Torremolinos

UA1002, Kyiv

UA1019, Odesa

UA1001, Poltava

UA1004, Ternopil

GB1051, Glasgow

GB1047, Liverpool

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

H. Lundbeck A/S

INDUSTRY