Vortioxetine in Patients With Depression and Early Dementia (MEMORY)

Lundbeck

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder; Dementia

Treatments: Drug: Vortioxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04294654

18315A

Details and patient eligibility

About

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia

Enrollment: 82 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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 20-24, inclusive.

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.

Other in- and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Vortioxetine

Experimental group

Description:

5 - 20 mg/day tablets

Treatment:

Drug: Vortioxetine