Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression

Lundbeck

Status and phase

Completed

Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: Vortioxetine tablets 10 mg/day

Drug: Placebo infusion

Drug: Placebo tablets

Drug: Vortioxetine infusion 25 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03766867

17915A

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days

Full description

The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient has recurrent MDD, diagnosed according to DSM-5® and confirmed using the Mini-International Neuropsychiatric Interview (MINI).
The patient has a MADRS total score ≥ 30 at the Screening Visit.
As part of standard of care treatment, the patient is to be admitted to hospital due to the severity of the depressive symptoms and is willing to remain hospitalized for the duration of the study treatment period.
The patient has had the current MDE for ≥3 months but less than 12 months.
The patient has received treatment for the current episode with an SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, sertraline) at an approved dose for at least 6 weeks.

Exclusion criteria

-The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the MINI or another diagnostic interview

Other in- and exclusion criteria may apply