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

Use our guide to learn which trials are right for you!

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