Background. Depression is a highly frequent condition in the elderly, with a huge impact on quality of life, life expectancy, and medical outcomes. This condition has also indirect costs related to the psychological and economic burden on family members, caregivers, and the wider society. SSRIs are the most commonly prescribed agents in elderly depressed patients and, although generally safe, they may be associated with tolerability issues. Vortioxetine is an antidepressants with a novel mechanism of action. Based on available studies, this drug has 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. Secondary outcomes will include: mortality, suicide, self-harm, occurrence of any adverse event, falls, bleeding, hyponatraemia, QTc prolongation. Validated rating scales will be administer by blind staff to assess efficacy and quality of life.