Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder (MDD)



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:7 - 11
Updated:3/27/2019
Start Date:May 2016
End Date:May 2021
Contact:Email contact via H. Lundbeck A/S
Email:LundbeckClinicalTrials@Lundbeck.com
Phone:+4536301311

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

Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Investigation of the efficacy and safety of a new potential treatment of Major depressive
disorder (MDD) in paediatric patients (age 7 to 11 years)


Inclusion Criteria:

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

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

3. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at
the Screening Visit and the Baseline.

4. The patient is a boy or girl, aged ≥7 and <12 years at Screening Visit

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

Exclusion Criteria:

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

2. The patient has previously participated in a study with vortioxetine.

Other protocol defined inclusion and exclusion criteria may apply
We found this trial at
41
sites
1266 Missouri Avenue
Saint Charles, Missouri 62201
?
mi
from
Saint Charles, MO
Click here to add this to my saved trials
Atlanta, Georgia 30044
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1328 U.S. 290 Frontage Road
Austin, Texas 78754
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Chicago, Illinois
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Creve Coeur, Missouri
?
mi
from
Creve Coeur, MO
Click here to add this to my saved trials
Dothan, Alabama
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Downey, California
?
mi
from
Downey, CA
Click here to add this to my saved trials
Gainesville, Florida
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
1118 West California Avenue
Glendale, California 84104
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hialeah, Florida
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Imperial, California
?
mi
from
Imperial, CA
Click here to add this to my saved trials
Lake Charles, Louisiana
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Little Rock, Arkansas 72023
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
1313 Georgia 3
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
1331 Tennessee 1
Memphis, Tennessee
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Middleburg Heights, Ohio
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
1315 Naperville Drive
Naperville, Illinois 60446
?
mi
from
Naperville, IL
Click here to add this to my saved trials
Naperville, Illinois
?
mi
from
Naperville, IL
Click here to add this to my saved trials
National City, California
?
mi
from
National City, CA
Click here to add this to my saved trials
1317 New York Avenue
New York, New York 11203
?
mi
from
New York, NY
Click here to add this to my saved trials
1329 Historic U.S. 66
Oklahoma City, Oklahoma 73118
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1323 Historic U.S. 66
Oklahoma City, Oklahoma 73118
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 74953
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California
?
mi
from
Orange, CA
Click here to add this to my saved trials
1229 Orange Avenue
Orange City, Florida 32092
?
mi
from
Orange City, FL
Click here to add this to my saved trials
Orem, Utah
?
mi
from
Orem, UT
Click here to add this to my saved trials
1370 Panorama Drive
Panorama City, California 94131
?
mi
from
Panorama City, CA
Click here to add this to my saved trials
1320 East Plano Parkway
Plano, Texas 75074
?
mi
from
Plano, TX
Click here to add this to my saved trials
Plano, Texas
?
mi
from
Plano, TX
Click here to add this to my saved trials
1222 New Jersey Street
Princeton, New Jersey 47670
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
Rochester, New York
?
mi
from
Rochester, NY
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Staten Island, New York
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Targovishte,
?
mi
from
Targovishte,
Click here to add this to my saved trials
1133 Columbia Street
Washington, District of Columbia 50057
?
mi
from
Washington,
Click here to add this to my saved trials
Wichita, Kansas
?
mi
from
Wichita, KS
Click here to add this to my saved trials