Depressive Disorder
Conditions
Keywords
Depressive Disorder, Moderate-severe depressive episode., Antidepressants, Psychotropics
Brief summary
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
Detailed description
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
Interventions
DRUGExperimental regimen
Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
DRUGControl regimen
Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blind for evaluators
Eligibility
Sex/Gender
ALL
Age
60 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile of esketamine nasal spray and aripiprazole | At week 32 | 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. |
| Clinical response | At week 32 | 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. |
| Free of relapse | At week 24, at week 32 | 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 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 | Score on the EuroQol-5D (EQ-5D) health-related quality of life scale in adults |
| Obtaining the transcriptome | At week 8, at week 32 | Obtaining the transcriptome of patients at week 8 and week 32 of treatment using a large-scale sequencer. |
Countries
Spain
Contacts
Primary ContactClara M Rosso Fernández, MD-PhD
Backup ContactBianca Sánchez Barbero
Outcome results
None listed