Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors

Status Completed

Clinical Trial 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 patients and, although generally safe, they may be associated with tolerability issues. Based on available studies, vortioxetine is likely to have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance, wakefulness, body weight, and electrocardiogram parameters. Objectives. Assessing the comparative tolerability, safety and efficacy of vortioxetine compared with the SSRIs as a group (including sertraline, citalopram, escitalopram, paroxetine, fluoxetine, fluvoxamine) in elderly patients affected by major depression. The primary outcome will be the withdrawal rate due to adverse events. Methods. This is a pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial. Twelve Italian Community Psychiatric Services will consecutively enrol elderly patients suffering from an episode of major depression who get in contact over a period of 12 months. By employing the web-based application RedCap, doctors will be able to randomize patients to vortioxetine or one of the SSRIs, chosen on the basis of clinical judgment, and to collect basic socio-demographic and clinical data. Trained and blinded assessors will administer five validated rating scales: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Charlson Age-Comorbidity Index (CACI), and Short Blessed Test (SBT). Patients will be assessed after 1, 3 and 6 months. Expected results. On the basis of current literature, the investigators hypothesize vortioxetine to be superior to SSRIs as a group in terms of tolerability. As vortioxetine is expected to reduce the withdrawal rates due to adverse events of about 12% compared to SSRIs, and assuming that about 23% of the participants could be lost within 6 months, the investigators aim to enrol 358 patients (179 in each group).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03779789
Study type	Interventional
Source	Azienda Ospedaliera Universitaria Integrata Verona
Contact
Status	Completed
Phase	Phase 4
Start date	February 1, 2019
Completion date	February 28, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05537558` - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated	`NCT02192099` - Open Label Extension for GLYX13-C-202, NCT01684163	Phase 2
Completed	`NCT03142919` - Lipopolysaccharide (LPS) Challenge in Depression	Phase 2
Recruiting	`NCT05547035` - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders	N/A
Terminated	`NCT02940769` - Neurobiological Effects of Light on MDD	N/A
Recruiting	`NCT05892744` - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression	Phase 4
Recruiting	`NCT05537584` - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment	Phase 4
Active, not recruiting	`NCT05061706` - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder	Phase 3
Completed	`NCT04479852` - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder	Phase 2
Recruiting	`NCT04032301` - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans	Phase 1
Recruiting	`NCT05527951` - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study	N/A
Completed	`NCT03511599` - Cycloserine rTMS Plasticity Augmentation in Depression	Phase 1
Recruiting	`NCT04392947` - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation	N/A
Recruiting	`NCT05895747` - 5-HTP and Creatine for Depression R33 Phase	Phase 2
Recruiting	`NCT05273996` - Predictors of Cognitive Outcomes in Geriatric Depression	Phase 4
Recruiting	`NCT05813093` - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression	N/A
Recruiting	`NCT05135897` - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation	`NCT04509102` - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder	Early Phase 1
Recruiting	`NCT06145594` - EMA-Guided Maintenance TMS for Depression	N/A
Recruiting	`NCT06026917` - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms