Status:
COMPLETED
Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsors:
University of Catania
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
Background. Depression is a highly frequent condition in the elderly, with a huge impact on quality of life, life expectancy, and medical outcomes. SSRIs are commonly prescribed in elderly depressed p...
Eligibility Criteria
Inclusion
- 65 years old or above;
- willing to participate by signing an informed consent;
- suffering from an episode of major depression, based on clinical judgment (guided by DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria);
- treatment with an antidepressant is clinically appropriate, based on clinical/medical judgment;
- agreement between investigator and patient to discontinue any current antidepressant, second generation antipsychotic, or lithium. According to the pragmatic design of the study, the discontinuation will be performed according to common routine practice. No specific protocols for discontinuation will be applied. All other concomitant medications are allowed;
- uncertainty about which trial treatment would be best for the participant.
Exclusion
- dementia, of any type and stage, as formally diagnosed by a specialist (geriatrician, neurologist, or others);
- diagnosis of schizophrenia or bipolar disorder;
- clinical conditions or treatments which contraindicate the use of oral vortioxetine or SSRIs, according to clinical/medical judgment (for example conditions or treatments at high risk of bleeding, convulsions, serotoninergic syndrome, hyponatraemia, etc.). All concomitant medications will be prescribed according to routine clinical practice, in compliance with the synthesis of the product characteristics (Riassunto delle Caratteristiche del Prodotto - RCP) registered in the databank of the AIFA (Agenzia Italiana del Farmaco) (available at https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/cerca-farmaco).
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT03779789
Start Date
February 1 2019
End Date
February 28 2023
Last Update
May 19 2023
Active Locations (3)
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1
Azienda Ospedaliera Universitaria Mater Domini, Università Magna Grecia
Catanzaro, Italy
2
Sapienza Università di Roma, Dipartimento di Neurologia e Psichiatria
Roma, Italy
3
Azienda Ospedaliera Universitaria Verona
Verona, Italy, 37134