Vortioxetine in Patients With Depression and Early Dementia

Interventional, open-label study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder and early dementia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001326-10-ES

Enrollment

100

Registered

2019-12-02

Start date

2019-12-26

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Depressive symptoms in patients with major depressive disorder (MDD) and early dementia MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Brintellix 5 mg Film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VORTIOXETINE CAS Number: 508233-74-7 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • The patient has a primary diagnosis of recurrent Major Depressive Disorder (MDD) with onset before age of 55, diagnosed 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) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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 International Neuropsychiatric Interview (MINI) or another diagnostic interview.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effectiveness of 12-week acute treatment with flexible dose 5-20 mg/day vortioxetine on depressive symptoms in patients with major depressive disorder (MDD) and early dementia;Secondary Objective: To assess the effectiveness of 12-week acute treatment with 5-20 mg/day vortioxetine on: • cognitive function • functioning • global clinical impression • depression • health-related quality of life;Primary end point(s): Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score;Timepoint(s) of evaluation of this end point: From baseline to Week 12	—

Measure

Time frame

Main Objective: To assess the effectiveness of 12-week acute treatment with flexible dose 5-20 mg/day vortioxetine on depressive symptoms in patients with major depressive disorder (MDD) and early dementia;Secondary Objective: To assess the effectiveness of 12-week acute treatment with 5-20 mg/day vortioxetine on: • cognitive function • functioning • global clinical impression • depression • health-related quality of life;Primary end point(s): Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score;Timepoint(s) of evaluation of this end point: From baseline to Week 12

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Secondary

Measure	Time frame
Secondary end point(s): • Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score* • Change in Rey Auditory Verbal Learning Test (RAVLT) score* • Change in Instrumental Activities of Daily Living (IADL) score* • Change in Clinical Global Impression - Severity (CGI-S) score* • Clinical Global Impression - Improvement (CGI-I) score • Response (defined as a 50% decrease from baseline in MADRS total score) • Remission (MADRS =10)** • Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score;Timepoint(s) of evaluation of this end point: From baseline to Week 12 ** At Week 12	—

Measure

Time frame

Secondary end point(s): • Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score* • Change in Rey Auditory Verbal Learning Test (RAVLT) score* • Change in Instrumental Activities of Daily Living (IADL) score* • Change in Clinical Global Impression - Severity (CGI-S) score* • Clinical Global Impression - Improvement (CGI-I) score** • Response (defined as a 50% decrease from baseline in MADRS total score)** • Remission (MADRS =10)** • Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score*;Timepoint(s) of evaluation of this end point: * From baseline to Week 12 ** At Week 12

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Countries

Estonia, Finland, France, Italy, Korea, Republic of, Spain, Switzerland

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