Clinical Trial Details

NCT ID: NCT02709746
Date Last Changed: September 6, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Depressive Disorder, Major

Research Study Title

Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)

Purpose

Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
12 to 17 Years
Overall Status
Recruiting
Lead Sponsor
H. Lundbeck A/S
Duration
29 Months
Facility Type
N/A
Compensation

Eligibility

All ages 12 Years to 17 Years

Inclusion Criteria:

  • The patient is a male or female, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study).

  • The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.

  • The patient has a CDRS-R total score ≥45 at the Screening Visit and at the Baseline.

  • The patient has a CGI-S score ≥4 at the Screening Visit and at the Baseline

  • The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

Exclusion Criteria:

  • The patient has participated in a clinical study < 30 days prior to the Screening Visit.

Other protocol defined inclusion and exclusion criteria may apply

Site Locations (102)

Country State City Zip Facility and Contact
United States Alabama Dothan US1369
United States Arizona Tucson US1333
United States Arkansas Little Rock US1310
United States California Costa Mesa US1062
United States California Downey US1387
United States California Escondido US1114
United States California Glendale US1118
United States California Imperial US1123
United States California Long Beach US1160
United States California Orange US1368
United States California Panorama City US1370
United States California Wildomar US1351
United States District of Columbia Washington, D.C. US1133
United States Florida Gainesville US1217
United States Florida Hialeah US1316
United States Florida Orange City US1229
United States Georgia Atlanta US1009
United States Georgia Marietta US1313
United States Illinois Naperville US1311
United States Illinois Naperville US1315
United States Illinois Oak Brook US1103
United States Kansas Wichita US1386
United States Louisiana Lake Charles US1261
United States Maryland Baltimore US1015
United States Mississippi Clinton US1385
United States Missouri Creve Coeur US1064
United States Missouri O'Fallon US1314
United States Missouri Saint Charles US1266
United States New Jersey Berlin US1312
United States New Jersey Princeton US1222
United States New York New York US1317
United States New York Rochester US1171
United States New York Staten Island US1190
United States Ohio Cincinnati US1051
United States Ohio Cleveland US1054
United States Ohio Middleburg Heights US1334
United States Oklahoma Oklahoma City US1227
United States Oklahoma Oklahoma City US1323
United States Oklahoma Oklahoma City US1325
United States Oklahoma Oklahoma City US1329
United States Texas Austin US1328
United States Texas Plano US1320
United States Texas San Antonio US1162
United States Utah Orem US1308
Bulgaria Targovishte BG1023
Bulgaria Varna BG1025
Canada Calgary CA1036
Canada Toronto CA1038
Estonia Tallinn EE1007
Estonia Viljandi EE1015
France Douai FR1041
France Elancourt FR1017
France Nantes FR1009
France Paris FR1019
France Rouen FR1007
Germany Freiburg DE1078
Germany Mainz DE1034
Germany Mannheim DE1077
Germany Maulbronn DE1081
Germany Tübingen DE1076
Hungary Budapest HU1023
Hungary Gyula HU1020
Italy Cagliari IT1075
Italy Firenze IT1071
Italy Genova IT1073
Italy Messina IT1029
Italy Napoli IT1068
Italy Padova IT1074
Italy Pisa IT1070
Italy Rome IT1072
Latvia Jelgava LV1002
Latvia Liepaja LV1008
Latvia Riga LV1009
Latvia Sigulda LV1007
Poland Bialystok PL1002
Poland Gdansk PL1050
Poland Kielce PL1068
Poland Lublin PL1057
Poland Poznan PL1052
Poland Toruń PL1053
Poland Wabrzych PL1054
Poland Wroclaw PL1051
Russian Federation Arkhangel'sk RU1009
Russian Federation Ekaterinburg RU1016
Russian Federation Krasnodar RU1046
Russian Federation Nizhniy Novgorod RU1004
Russian Federation Novosibirsk RU1010
Russian Federation Rostov on Don RU1012
Russian Federation Saratov RU1013
Russian Federation Saratov RU1038
Russian Federation St.Petersburg RU1030
Russian Federation Tonnel'nyy RU1048
South Africa Cape Town ZA1019
South Africa Randburg ZA1022
South Africa Sandton ZA1023
Spain Alcorcon ES1041
Spain Madrid ES1044
Spain Pamplona ES1043
Spain Sabadell ES1018
Spain Torremolinos ES1040
United Kingdom Glasgow GB1051
United Kingdom Liverpool GB1047

Contact

Email contact via H.Lundbeck A/S
+4536301311
E-mail:

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