NCT02709655

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

Interventional, Randomized, 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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 683 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Vortioxetine 10 mg/day	10 mg/day, encapsulated tablet, orally (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, orally (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 20mg/day	20 mg/day, encapsulated tablet, orally (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, orally

Timeline

• Start date: 2016-05-18
• Primary completion: 2022-01-21
• Completion: 2022-01-21
• First posted: 2016-03-16
• Last updated: 2022-09-22
• Results posted: 2022-09-22

Locations

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

Regulatory

• FDA-regulated drug study