A Phase 3 interventional study of Experimental regimen and Control regimen in Depressive Disorder, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Not yet recruiting at 9 sites in Spain. Open to participants aged 60 Years to 74 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Phase 3, Interventional, and Treatment
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
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 220 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Esketamine intranasal spray at flexible doses 28, 56 and 84 mg once or twice a week
Drug: Experimental regimen
Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Drug: Control regimen
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
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)
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
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla