Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment

PHASE4CompletedINTERVENTIONAL
Enrollment

362

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

Conditions
Major Depressive Disorder
Interventions
DRUG

Vortioxetine

"Antidepressant classified under the category other antidepressants according to the ATC/DDD index \[ATC=Anatomical Therapeutic Chemical Classification System; DDD=Defined Daily Dose\]. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 5-20 mg/day)."

DRUG

Sertraline

"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 50-200 mg/day)."

DRUG

citalopram

"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 10-20 mg/day)."

DRUG

Escitalopram

"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 5-10 mg/day)."

DRUG

Paroxetine

"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 20-40 mg/day)."

DRUG

Fluoxetine

"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 20-60 mg/day)."

DRUG

Fluvoxamine

"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 100-300 mg/day)."

Trial Locations (3)

37134

Azienda Ospedaliera Universitaria Verona, Verona

Unknown

Azienda Ospedaliera Universitaria Mater Domini, Università Magna Grecia, Catanzaro

Sapienza Università di Roma, Dipartimento di Neurologia e Psichiatria, Roma

All Listed Sponsors
collaborator

University of Catania

OTHER

lead

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

NCT03779789 - Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment | Biotech Hunter | Biotech Hunter