Study With Vortioxetine on Emotional Functioning in Patients With Depression

Interventional, open-label, flexible-dose study of vortioxetine on emotional functioning in patients with major depressive disorder with inadequate response to SSRI/SNRI treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004829-33-FR

Enrollment

150

Registered

2018-07-04

Start date

2018-10-03

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional functioning in patients with MDD MedDRA version: 20.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Brintellix 10 mg Film-coated tablets Product Name: Brintellix Pharmaceutical Form: Film-coated tablet INN or Proposed INN: vortioxetine CAS Number: 508233-74-7 Other descriptive name: AA

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to 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

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

Measure

Time frame

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

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Countries

France, Italy, Lithuania, Spain

Contacts

Public ContactLundbeckClinicalTrials@lundbeck.com

H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com004536301311

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026