Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression (VIVRE)

Lundbeck

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Desvenlafaxine; Drug: Vortioxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04448431

18498A

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit

Full description

The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.

At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.

Enrollment: 605 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
• The patient has a MADRS total score ≥24 at screening and baseline.
• The patient has had the current MDE for ≥3 months and < 12 months.
• The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
• The patient wants to switch antidepressant treatment.

Exclusion criteria

• The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.

Other in- and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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605 participants in 2 patient groups

Vortioxetine

Experimental group

Description:

8 weeks treatment

Treatment:

Drug: Vortioxetine

Desvenlafaxine

Active Comparator group

Description:

8 weeks treatment

Treatment:

Drug: Desvenlafaxine