Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Препарат Experimental regimen
  Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
• Препарат Control regimen
  Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study

Первичные конечные точки

• Clinical response [Срок оценки: At week 8]

Вторичные конечные точки (6)

• Safety profile of esketamine nasal spray and aripiprazole [Срок оценки: At week 32]
• Clinical response [Срок оценки: At week 32]
• Safety profile of esketamine nasal spray and aripiprazole [Срок оценки: At week 8]
• Free of relapse [Срок оценки: At week 24, at week 32]
• Score on the EuroQol-5D scale (www.euroqol.org) [Срок оценки: 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 [Срок оценки: At week 8, at week 32]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 9 центров

• Clínica Psiquiátrica Padre Menni — Pamplona
• Hospital Vall d'Hebron — Barcelona
• Hospital De La Santa Creu i Sant Pau — Barcelona
• Hospital Mare de Déu de La Mercè — Barcelona
• Hospital Sagrat Cor. Martorell — Barcelona
• Hospital Benito Menni y Fidmag Hermanas Hospitalarias — Barcelona
• Centro Sociosanitario Hermanas Hospitalarias de Palencia — Palencia
• Corporacion Sanitaria Parc Tauli — Sabadell
• … и ещё 1 центр

Идентификаторы

NCT: NCT07153406 · CESAR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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