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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Clínica Psiquiátrica Padre Menni
Pamplona, Navarre, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital De La Santa Creu i Sant Pau
Barcelona, Spain
Hospital Mare de Déu de La Mercè
Barcelona, Spain
Clinical response
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)
Time frame: At week 8
Safety profile of esketamine nasal spray and aripiprazole
Determination of the safety profile of esketamine nasal spray and aripiprazole in patients free of relapse at week 32, according to the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 throughout the study.
Time frame: At week 32
Clinical response
Clinical response 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 compared to the initial score and a score ≤4 on the CGI severity scale.
Time frame: At week 32
Safety profile of esketamine nasal spray and aripiprazole
Determination of the safety profile of esketamine nasal spray and aripiprazole at week 8, according to the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 throughout the study.
Time frame: At week 8
Free of relapse
Proportion of patients free of relapse at week 24 and week 32 in the group of patients with clinical remission at week 8.
Time frame: At week 24, at week 32
Score on the EuroQol-5D scale (www.euroqol.org)
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Hospital Sagrat Cor. Martorell
Barcelona, Spain
Hospital Benito Menni y Fidmag Hermanas Hospitalarias
Barcelona, Spain
Centro Sociosanitario Hermanas Hospitalarias de Palencia
Palencia, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Score on the EuroQol-5D (EQ-5D) health-related quality of life scale in adults
Time frame: 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
Obtaining the transcriptome of patients at week 8 and week 32 of treatment using a large-scale sequencer.
Time frame: At week 8, at week 32