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

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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

Key facts

Study ID

NCT02709655

Run by

H. Lundbeck A/S

People needed

683

Starts

2016-05-18

Expected to finish

2022-01-21

Last updated by the study team

2022-09-22

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
• The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
• The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
• The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit
• The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.

You may not qualify if…

• The participant has participated in a clinical study <30 days prior to the Screening Visit.
• The participant has previously participated in a study with vortioxetine.
• Other protocol defined inclusion and exclusion criteria may apply

Where it is running

• Sun Valley Research Center — Imperial, California, United States
• Synergy Clinical Research Center — Lemon Grove, California, United States
• Alliance for Wellness dba Alliance for Research — Long Beach, California, United States
• NRC Research Institute — Orange, California, United States
• Asclepes Research Center — Panorama City, California, United States
• Children's National Medical Center Merge — Washington D.C., District of Columbia, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Northwest Behavioral Research Center — Marietta, Georgia, United States
• American Medical Research, Inc. — Chicago, Illinois, United States
• AMR- Baber Research, Inc. — Naperville, Illinois, United States
• AMR Conventions Research — Warrenville, Illinois, United States
• Kansas University School of Medicine-Wichita — Wichita, Kansas, United States
• Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• St. Charles Psychiatric Associates - Midwest Research Group — Saint Charles, Missouri, United States
• Millennium Psychiatric Associates, LLC — St Louis, Missouri, United States
• Princeton Medical Institute — Princeton, New Jersey, United States
• Manhattan Behavioral Medicine — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry — Cleveland, Ohio, United States
• North Star Medical Research, LLC — Middleburg Heights, Ohio, United States
• Woodland International Research Group — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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