Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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).

Key facts

Study ID

NCT02709746

Run by

H. Lundbeck A/S

People needed

784

Starts

2016-05-01

Expected to finish

2019-07-30

Last updated by the study team

2020-08-19

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline.
• The patient has a Clinical Global Impression - Severity of Illness (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.

You may not qualify if…

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

Where it is running

• US1333 — Tucson, Arizona, United States
• US1310 — Little Rock, Arkansas, United States
• US1062 — Costa Mesa, California, United States
• US1387 — Downey, California, United States
• US1114 — Escondido, California, United States
• US1118 — Glendale, California, United States
• US1123 — Imperial, California, United States
• US1160 Renew Behavioral Health, Inc. — Long Beach, California, United States
• US1368 — Orange, California, United States
• US1370 — Panorama City, California, United States
• US1351 — Wildomar, California, United States
• US1133 — Washington D.C., District of Columbia, United States
• US1217 — Gainesville, Florida, United States
• US1229 — Orange City, Florida, United States
• US1009 — Atlanta, Georgia, United States
• US1313 — Marietta, Georgia, United States
• US1311 — Naperville, Illinois, United States
• US1315 — Naperville, Illinois, United States
• US1103 — Oak Brook, Illinois, United States
• US1386 — Wichita, Kansas, United States
• US1261 — Lake Charles, Louisiana, United States
• US1015 — Baltimore, Maryland, United States
• US1385 Ericksen Research And Development — Clinton, Mississippi, United States
• US1064 — Creve Coeur, Missouri, United States
• US1369 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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