Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 3
- 主要终点
- Number of participants withdrawing from treatment due to adverse events (tolerability)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
vortioxetine
干预措施: Vortioxetine (Drug)
SSRIs
干预措施: Sertraline (Drug)
SSRIs
干预措施: citalopram (Drug)
SSRIs
干预措施: Escitalopram (Drug)
SSRIs
干预措施: Paroxetine (Drug)
SSRIs
干预措施: Fluoxetine (Drug)
SSRIs
干预措施: Fluvoxamine (Drug)
结局指标
主要结局
Number of participants withdrawing from treatment due to adverse events (tolerability)
时间窗: 6 months
Participants withdrawing from allocated treatment due to adverse events on the number of randomized patients.
次要结局
- Number of participants died by suicide(6 months)
- Number of participants with at least one episode of self-harm(6 months)
- Treatment-related adverse events as assessed by the ASEC(6 months)
- Number of participants with a reduction of at least 50% of the baseline score of the MADRS (responders)(6 months)
- Quality of life as assessed by the EQ-5D(6 months)
- Overall mortality(6 months)
- Number of participants withdrawing from treatment due to any cause (acceptability)(6 months)
- Efficacy on depressive symptoms as assessed by the MADRS(6 months)
- Cognitive performance as assessed by the SBT(6 months)