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

Phase 1

Conditions: Major depressive disorder
MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2019-002704-41-EE

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

- The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a Montgomery and Åsberg Depression Rating Scale (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 and with a partial response and is a candidate for a switch in the investigator’s opinion.
- The patient wants to switch antidepressant treatment.
Other inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: N/A;Primary end point(s): 1. Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score<br>The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.<br>;Timepoint(s) of evaluation of this end point: 1. Time-frame: From baseline to Week 8

Secondary Outcome Measures

Name	Time	Method

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