NCT01422213

Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of [Vortioxetine] Lu AA21004 on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 598 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD primarily involves mood disturbances, patients also usually present alterations in cognitive function (attention, memory, executive functioning and psychomotor speed). Even though antidepressants are suggested in the literature to potentially improve cognitive dysfunction in patients with MDD to some degree, there is a lack of adequate and well-controlled studies to investigate this effect. This study will evaluate the efficacy, safety and tolerability of a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients with MDD.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	capsules; daily; orally
DRUG	Vortioxetine (Lu AA21004)	encapsulated tablets; daily; orally
DRUG	Vortioxetine (Lu AA21004)	encapsulated tablets; daily; orally

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-05-01
• First posted: 2011-08-23
• Last updated: 2014-08-05
• Results posted: 2014-08-05