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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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
Orem, Utah
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Atlanta, Georgia 30044
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Atlanta, GA
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1328 U.S. 290 Frontage Road
Austin, Texas 78754
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Austin, TX
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Baltimore, Maryland
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Baltimore, MD
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Berlin, New Jersey 08009
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Berlin, NJ
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Cincinnati, Ohio
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Cleveland, Ohio
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Clinton, MS
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Costa Mesa, California
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Creve Coeur, Missouri
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Creve Coeur, MO
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Dothan, Alabama
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Downey, California
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Downey, CA
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Escondido, California
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Escondido, CA
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Gainesville, Florida
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Gainesville, FL
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1118 West California Avenue
Glendale, California 84104
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Glendale, CA
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Imperial, California
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Imperial, CA
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Lake Charles, Louisiana
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Lake Charles, LA
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Little Rock, Arkansas 72023
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Little Rock, AR
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Long Beach, California
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Long Beach, CA
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1313 Georgia 3
Marietta, Georgia 30060
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Marietta, GA
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Middleburg Heights, Ohio
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Middleburg Heights, OH
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Naperville, Illinois
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Naperville, IL
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1315 Naperville Drive
Naperville, Illinois 60446
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1317 New York Avenue
New York, New York 11203
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New York, NY
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1314 Old US Highway 40
O'Fallon, Missouri 63366
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1103 Oak Brook Road
Oak Brook, Illinois 60523
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Oak Brook, IL
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1323 Historic U.S. 66
Oklahoma City, Oklahoma 73118
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Oklahoma City, OK
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1329 Historic U.S. 66
Oklahoma City, Oklahoma 73118
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Orange, California
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Orange, CA
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1229 Orange Avenue
Orange City, Florida 32092
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1370 Panorama Drive
Panorama City, California 94131
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Panorama City, CA
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1320 East Plano Parkway
Plano, Texas 75074
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Plano, TX
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1222 New Jersey Street
Princeton, New Jersey 47670
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Richmond, Virginia 23005
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Richmond, VA
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Rochester, New York
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Rochester, NY
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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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Targovishte,
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1333 East 2nd Street
Tucson, Arizona 85719
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Tucson, AZ
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1133 Columbia Street
Washington, District of Columbia 50057
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Wichita, Kansas
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1351 Wildomar Street
Wildomar, California 90272
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Wildomar, CA
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