Study With Vortioxetine on Emotional Functioning in Patients With Depressio

Phase 1

• Conditions: Emotional functioning in patients with MDD; MedDRA version: 20.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-004829-33-FR
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The patient has a primary diagnosis of single or recurrent MDD according
to DSM-5®. The current major depressive episode (MDE) must be
confirmed using the Mini International Neuropsychiatric Interview (MINI).
• The patient has had the current MDE for <12 months.
• The patient has a Montgomery and Åsberg Depression Rating Scale
(MADRS) total score = 22 and = 28 at the Baseline Visit.
• The patient has been treated with SSRI/SNRI monotherapy (citalopram,
escitalopram, paroxetine, duloxetine or venlafaxine) for at least 6 weeks at
adequate dose for the current MDE and with an inadequate response and
is a candidate for a switch in the investigator’s opinion.
• The patient wants to switch antidepressant treatment.
• The patient has an ODQ total score =50 at baseline, while on SSRI/SNRI
monotherapy (prior to switch).
• The patient answered Yes to the screening question on emotional effects.
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 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The patient has a significant risk of suicide according to the investigator’s
clinical judgment or has made an actual suicide attempt in the previous 6
months prior to Baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day<br>on emotional functioning in patients with MDD with an inadequate response to<br>SSRIs/SNRIs.;Secondary Objective: NA;Primary end point(s): Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total score;Timepoint(s) of evaluation of this end point: From baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline to Week 8 in MEI total score<br>Change from baseline to Week 8 in DSST total score<br>Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC)<br>Change from baseline to Week 8 in MADRS total score<br>Change from baseline to Week 8 in SDS individual item scores (family, work, and social life)<br>Change from baseline to Week 8 in SDS total scores<br>Change from baseline to Week 8 in CGI-S score<br>CGI-I score at Week 8;Timepoint(s) of evaluation of this end point: From baseline to Week 8