Vortioxetine in Patients With Depression and Early Dementia

• Status: Recruiting
• Trial end date: 2022-04-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Collaborator: ICON plc
• Treatments: Vortioxetine

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 <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