Conditions: Depressive Disorder, Major
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 602
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.

Detailed description:
Lu AA21004 is under codevelopment by Takeda Global Research \& Development Center, Inc. and H. Lundbeck A/S for the treatment of MDD.

This study will consist of a screening period within 10 days of the Baseline Visit followed by an 8-week double-blind treatment period and a one-week taper down period.

Arms:
arm 1: Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. arm 2: Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period. arm 3: Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).

Interventions: intervention 1: vortioxetine (Lu AA21004) intervention 2: Duloxetine intervention 3: Placebo
Intervention descriptions: intervention 1: Lu AA21004 capsules intervention 2: Duloxetine capsules intervention 3: Placebo matching capsules

Protocol document: