Status:
COMPLETED
Vortioxetine in Patients With Depression and Early Dementia
Lead Sponsor:
H. Lundbeck A/S
Collaborating Sponsors:
ICON plc
Conditions:
Major Depressive Disorder
Dementia
Eligibility:
All Genders
55-85 years
Phase:
PHASE4
Brief Summary
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04294654
Start Date
February 28 2020
End Date
July 20 2022
Last Update
August 8 2022
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Marienthali Kliinik
Tallinn, Estonia, 11315
2
Cabinet du Docteur Karim Boutayeb
Viersat, France, 23170
3
Centre de Recherche-Hopital Geriatrique de Charpennes
Villeurbanne, France, 69100
4
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
Brescia, Province Of Brescia, Italy, 25123