Vortioxetine in Patients With Depression and Early Dementia

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

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 <6 months.
• The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score =26 at the Baseline Visit.
• The diagnosis of onset of dementia has occurred at least 6 months prior to screening and after already being diagnosed with MDD. The diagnosis of dementia must be documented in patient's medical records. When deemed necessary per investigator judgement of patient clinical status and early dementia, the patient must be accompanied by a caregiver to study visits.
• Patients with dementia associated with vitamin B12 or folate deficiency should not be enrolled.
• Patients with or without treatment for dementia can be enrolled. For patients on treatment for dementia, there must be no change in treatment during the study and patients must be on stable dose for at least 3 months prior to the Screening Visit.
• The patient has Mini Mental State Examination (MMSE) total score 2024, inclusive.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>• cognitive function<br>• functioning<br>• global clinical impression<br>• depression<br>• 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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score<br>• Change in Rey Auditory Verbal Learning Test (RAVLT) score<br>• Change in Instrumental Activities of Daily Living (IADL) score<br>• Change in Clinical Global Impression - Severity (CGI-S) score<br>• Clinical Global Impression - Improvement (CGI-I) score<br>• Response (defined as a 50% decrease from baseline in MADRS total score)<br>• Remission (MADRS =10)*<br>• 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<br>** At Week 12

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