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

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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
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1133 Columbia Street
Washington, District of Columbia 50057
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Atlanta, Georgia 30044
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1328 U.S. 290 Frontage Road
Austin, Texas 78754
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Baltimore, Maryland
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Chicago, Illinois
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Cincinnati, Ohio
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Cleveland, Ohio
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Clinton, Utah 84015
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Creve Coeur, Missouri
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Dothan, Alabama
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Downey, California
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Gainesville, Florida
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1118 West California Avenue
Glendale, California 84104
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Hialeah, Florida
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Imperial, California
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Lake Charles, Louisiana
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Little Rock, Arkansas 72023
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1313 Georgia 3
Marietta, Georgia 30060
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1331 Tennessee 1
Memphis, Tennessee
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Middleburg Heights, Ohio
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1315 Naperville Drive
Naperville, Illinois 60446
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Naperville, Illinois
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National City, California
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1317 New York Avenue
New York, New York 11203
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1329 Historic U.S. 66
Oklahoma City, Oklahoma 73118
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Oklahoma City, Oklahoma
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1323 Historic U.S. 66
Oklahoma City, Oklahoma 73118
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Oklahoma City, Oklahoma 74953
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Orange, California
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1229 Orange Avenue
Orange City, Florida 32092
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Orem, Utah
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1370 Panorama Drive
Panorama City, California 94131
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1320 East Plano Parkway
Plano, Texas 75074
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Plano, Texas
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1222 New Jersey Street
Princeton, New Jersey 47670
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Rochester, New York
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1266 Missouri Avenue
Saint Charles, Missouri 62201
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San Antonio, Texas
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Staten Island, New York
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Targovishte,
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Wichita, Kansas
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