2024-512672-34-00招募中3 期
Comparison between esketamine nasal spray versus aripiprazole, both in combination with an antidepressant, in the refractory major depression disorder (RMDD) in elderly patients (CESAR)
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla11 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2024年11月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 11
- 主要终点
- Clinical response at week 8 after initiation of treatment, measured in terms of: - Remission of depressive symptoms; total score ≤10 on the MADRS 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.
研究概览
简要总结
To evaluate the efficacy of esketamine nasal spray at flexible doses compared to aripiprazole at 8 weeks, both in combination with a continued antidepressant, in elderly participants (>60 years), who suffer from refractory major depression disorder (RMDD) with one episode current moderate to severe depressive disorder.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 an SSRI (Selective Serotonin Reuptake Inhibitors) /SNRI (Serotonin–norepinephrine reuptake inhibitors) at the time of screening that is not responding (less than 25% improvement in symptoms) after receiving an adequate dose [SmPC; 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
结局指标
主要结局
Clinical response at week 8 after initiation of treatment, measured in terms of: - Remission of depressive symptoms; total score ≤10 on the MADRS 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 response at week 8 after initiation of treatment, measured in terms of: - Remission of depressive symptoms; total score ≤10 on the MADRS 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.
次要结局
- Clinical response at week 32 after initiation of treatment, measured in terms of: - Remission of depressive symptoms; total score ≤10 on the MADRS 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.
- Determination of the safety profile of esketamine nasal spray and aripiprazole at week 8, as assessed by the established safety committee
- Determination of the safety profile of esketamine nasal spray and aripiprazole at week 32 in those patients who were relapse-free at week 8, as assessed by the established safety committee
- Proportion of patients free of relapse at week 24 and week 32 in the group of patients with clinical remission at week 8.
- Score on the EuroQol-5D (EQ-5D) scale for health-related quality of life in adults
- Whole genome sequencing of trial participants using variant filtering and prioritization routinely performed in the HUVR laboratory.
- Obtaining the transcriptome of trial participants at week 8 and week 32 of treatment using a large-scale sequencer
- Integration of participants’ exome and transcriptome findings with other omics.
- To determine the immune activation and inflammation profiles in both treatment groups
- Deep immunophenotyping by flow cytometry of peripheral blood cells in both treatment groups
- Determine the activity profiles of relevant pathways in both treatment arms
研究者
Clinical Trial Unit IBIS/University Hospital Virgen del Rocío
Scientific
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
研究点 (11)
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