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
US1317
1317 New York Avenue
New York, New York 11203
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New York, NY
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US1009
Atlanta, Georgia 30044
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Atlanta, GA
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US1328
1328 U.S. 290 Frontage Road
Austin, Texas 78754
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Austin, TX
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US1015
Baltimore, Maryland
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Baltimore, MD
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US1312
Berlin, New Jersey 08009
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Berlin, NJ
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US1051
Cincinnati, Ohio
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Cincinnati, OH
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US1054
Cleveland, Ohio
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Cleveland, OH
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US1385 Ericksen Research And Development
Clinton, Mississippi
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Clinton, MS
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US1062
Costa Mesa, California
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Costa Mesa, CA
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US1064
Creve Coeur, Missouri
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Creve Coeur, MO
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US1369
Dothan, Alabama
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Dothan, AL
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US1387
Downey, California
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Downey, CA
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US1114
Escondido, California
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Escondido, CA
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US1217
Gainesville, Florida
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Gainesville, FL
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US1118
1118 West California Avenue
Glendale, California 84104
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Glendale, CA
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US1123
Imperial, California
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Imperial, CA
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US1261
Lake Charles, Louisiana
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Lake Charles, LA
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US1310
Little Rock, Arkansas 72023
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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
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Marietta, GA
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US1334
Middleburg Heights, Ohio
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Middleburg Heights, OH
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US1311
Naperville, Illinois
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Naperville, IL
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US1315
1315 Naperville Drive
Naperville, Illinois 60446
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Naperville, IL
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US1314
1314 Old US Highway 40
O'Fallon, Missouri 63366
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O'Fallon, MO
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US1103
1103 Oak Brook Road
Oak Brook, Illinois 60523
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Oak Brook, IL
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US1323
1323 Historic U.S. 66
Oklahoma City, Oklahoma 73118
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Oklahoma City, OK
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US1329
1329 Historic U.S. 66
Oklahoma City, Oklahoma 73118
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Oklahoma City, OK
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US1368
Orange, California
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Orange, CA
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US1229
1229 Orange Avenue
Orange City, Florida 32092
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Orange City, FL
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US1308
Orem, Utah
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Orem, UT
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US1370
1370 Panorama Drive
Panorama City, California 94131
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Panorama City, CA
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US1320
1320 East Plano Parkway
Plano, Texas 75074
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Plano, TX
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US1222
1222 New Jersey Street
Princeton, New Jersey 47670
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Princeton, NJ
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US1309
Richmond, Virginia 23005
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Richmond, VA
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US1171
Rochester, New York
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Rochester, NY
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US1266
1266 Missouri Avenue
Saint Charles, Missouri 62201
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Saint Charles, MO
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US1162
San Antonio, Texas
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San Antonio, TX
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US1190
Staten Island, New York
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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
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Tucson, AZ
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US1133
1133 Columbia Street
Washington, District of Columbia 50057
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US1386
Wichita, Kansas
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Wichita, KS
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US1351
1351 Wildomar Street
Wildomar, California 90272
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Wildomar, CA
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