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
US1217
Gainesville, Florida
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Gainesville, FL
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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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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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US1317
1317 New York Avenue
New York, New York 11203
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New York, NY
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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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Washington,
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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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