Comparison of Esketamine Versus Aripiprazole,Both in Combination With a SSRI/SNRI(Selective Serotonin Reuptake Inhibitors/Serotonin and Norepinephrine Reuptake Inhibitors )in Treatment-resistant Major Depressive Disorder in Elderly Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- Clinical response
研究概览
简要总结
Phase III, open label, randomised, multicentre, blind for evaluators clinical trial to evaluate the efficacy of esketamine nasal spray at flexible dosis compared to aripiprazole in elderly participants (>60 years) who suffer from treatment-resistant major depressive
详细描述
The study disease is resistant major depressive disorder, which has not responded to at least three different strategies with antidepressants, at least one of them being a combination or potentiation strategy, with a current moderate-severe depressive episode.
The aim of the study is to evaluate the efficacy of esketamine nasal spray at flexible dosis compared to aripiprazole at 8 weeks, both in combination with a continued antidepressant, in elderly participants (>60 years), who suffer from treatment-resistant major depressive disorder with one episode current moderate to severe depressive disorder
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)
盲法说明
Blind for evaluators
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 60-74 years
- •To be receiving antidepressant treatment that includes an antidepressant at the time of screening that is not responding (less than 25% improvement in symptoms) after receiving an adequate dose [or local equivalent, if applicable] for at least 6 weeks and have been increased to the dose maximum allowed
- •Current antidepressant treatment must have been immediately preceded by failure to respond to at least 3, but not more than 5, different consecutive treatments (all within the same moderately severe depressive episode) with antidepressant drugs (AD) taken at an appropriate dose for at least least 6 weeks (3 antidepressant failures including the current one)
- •To have been treated with at least 3 different classes of antidepressants between treatments taken at appropriate doses for at least 6 weeks without response in the current moderate to severe depressive episode (including current treatment with an antidepressant)
- •To be taking a single oral antidepressant on day 1 before randomization
- •Participants who, at the time of screening, are taking a combination of antidepressants and/or rescue treatment (other than aripiprazole) for the current moderate to severe depressive episode may participate in the study.
排除标准
- •Treatment with drugs contraindicated with the use of esketamine and aripiprazole.
- •Patients in whom a high risk of suicide is detected at the screening visit, according to the criteria established by Columbia University according to the C-SSRS evaluation
- •Patients who are participating in another clinical trial with active treatment
- •Patients who do not have the capacity to consent to participation in the trial or who do not have a representative to confirm their participation
- •Hypersensitivity to any of the active ingredients of any of the branches of treatment, or to any of the excipients of its pharmaceutical form
- •Patients in whom increased blood pressure or blood pressure intracranial fluid poses a serious risk
研究组 & 干预措施
Esketamine
Esketamine intranasal spray at flexible doses 28, 56 and 84 mg once or twice a week
干预措施: Experimental regimen (Drug)
aripiprazole
Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
干预措施: Control regimen (Drug)
结局指标
主要结局
Clinical response
时间窗: At week 8
Clinical response at week 8 after initiation of treatment, measured in terms of: * Remission of depressive symptoms; total score ≤10 on the MADRS (Montgomery-Asberg Depression Rating Scale )scale. * Adequate clinical response, if they show a reduction of ≥50% in the total score of the MADRS scale with respect to the initial score and a score ≤4 on the CGI severity scale. (Clinical Global Impression)
次要结局
- Safety profile of esketamine nasal spray and aripiprazole(At week 8)
- Clinical response(At week 32)
- Free of relapse(At week 24, at week 32)
- Score on the EuroQol-5D scale (www.euroqol.org)(At day 1, at day 8, at day 15, at day 22, at week 5 to 8, at week 9 to 32, at week 34)
- Obtaining the transcriptome(At week 8, at week 32)