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



Status:Active, not recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 17
Updated:3/27/2019
Start Date:May 2016
End Date:April 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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)

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).


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
We found this trial at
43
sites
US1315
1315 Naperville Drive
Naperville, Illinois 60446
583
mi
from
Naperville, IL
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US1009
Atlanta, Georgia 30044
813
mi
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Atlanta, GA
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US1328
1328 U.S. 290 Frontage Road
Austin, Texas 78754
513
mi
from
Austin, TX
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US1015
Baltimore, Maryland
1148
mi
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Baltimore, MD
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US1312
Berlin, New Jersey 08009
1237
mi
from
Berlin, NJ
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US1051
Cincinnati, Ohio
728
mi
from
Cincinnati, OH
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US1054
Cleveland, Ohio
894
mi
from
Cleveland, OH
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US1385 Ericksen Research And Development
Clinton, Mississippi
?
mi
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Clinton, MS
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US1062
Costa Mesa, California
1160
mi
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Costa Mesa, CA
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US1064
Creve Coeur, Missouri
406
mi
from
Creve Coeur, MO
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US1369
Dothan, Alabama
838
mi
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Dothan, AL
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US1387
Downey, California
1165
mi
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Downey, CA
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US1114
Escondido, California
1128
mi
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Escondido, CA
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US1217
Gainesville, Florida
1049
mi
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Gainesville, FL
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US1118
1118 West California Avenue
Glendale, California 84104
781
mi
from
Glendale, CA
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US1123
Imperial, California
1054
mi
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Imperial, CA
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US1261
Lake Charles, Louisiana
582
mi
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Lake Charles, LA
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US1310
Little Rock, Arkansas 72023
378
mi
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Little Rock, AR
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US1160 Renew Behavioral Health, Inc.
Long Beach, California
?
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Long Beach, CA
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US1313
1313 Georgia 3
Marietta, Georgia 30060
790
mi
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Marietta, GA
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US1334
Middleburg Heights, Ohio
885
mi
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Middleburg Heights, OH
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US1311
Naperville, Illinois
582
mi
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Naperville, IL
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US1317
1317 New York Avenue
New York, New York 11203
1289
mi
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New York, NY
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US1314
1314 Old US Highway 40
O'Fallon, Missouri 63366
394
mi
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O'Fallon, MO
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US1103
1103 Oak Brook Road
Oak Brook, Illinois 60523
594
mi
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Oak Brook, IL
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US1323
1323 Historic U.S. 66
Oklahoma City, Oklahoma 73118
155
mi
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Oklahoma City, OK
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US1329
1329 Historic U.S. 66
Oklahoma City, Oklahoma 73118
155
mi
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Oklahoma City, OK
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US1368
Orange, California
1153
mi
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Orange, CA
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US1229
1229 Orange Avenue
Orange City, Florida 32092
1081
mi
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Orange City, FL
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US1308
Orem, Utah
764
mi
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Orem, UT
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US1370
1370 Panorama Drive
Panorama City, California 94131
1341
mi
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Panorama City, CA
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US1320
1320 East Plano Parkway
Plano, Texas 75074
333
mi
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Plano, TX
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US1222
1222 New Jersey Street
Princeton, New Jersey 47670
559
mi
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Princeton, NJ
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US1309
Richmond, Virginia 23005
1111
mi
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Richmond, VA
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US1171
Rochester, New York
1122
mi
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Rochester, NY
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US1266
1266 Missouri Avenue
Saint Charles, Missouri 62201
420
mi
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Saint Charles, MO
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US1162
San Antonio, Texas
576
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San Antonio, TX
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US1190
Staten Island, New York
1279
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Staten Island, NY
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BG1023
Targovishte,
?
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Targovishte,
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US1333
1333 East 2nd Street
Tucson, Arizona 85719
834
mi
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Tucson, AZ
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US1133
1133 Columbia Street
Washington, District of Columbia 50057
343
mi
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Washington,
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US1386
Wichita, Kansas
26
mi
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Wichita, KS
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US1351
1351 Wildomar Street
Wildomar, California 90272
1184
mi
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Wildomar, CA
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