NCT02709746

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 784 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Vortioxetine 10 mg/day	10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
DRUG	Vortioxetine 20 mg/day	20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
DRUG	Fluoxetine 20 mg/day	20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
OTHER	Placebo	Encapsulated tablet

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-07-02
• Completion: 2019-07-30
• First posted: 2016-03-16
• Last updated: 2020-08-19
• Results posted: 2020-08-19

Locations

124 sites across 19 countries: United States, Bulgaria, Canada, Colombia, Estonia, France, Germany, Hungary, Italy, Latvia, Mexico, Poland, Russia, Serbia, South Africa, South Korea, Spain, Ukraine, United Kingdom