Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment
Status:
Unknown status
Trial end date:
2020-01-31
Target enrollment:
Participant gender:
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).